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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL068060 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine the effectiveness of nasal continuous positive airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).
BACKGROUND:
Nasal CPAP therapy is in widespread use as the primary treatment for OSAS, a sleep-related breathing disorder affecting more than 15 million Americans. The therapeutic effectiveness of CPAP in providing significant, stable, and long-term neurocognitive or other functional benefits to patients with OSAS has not been systematically investigated.
DESIGN NARRATIVE:
The study is a randomized, blinded, sham-controlled, multi-center trial of CPAP therapy. The principal aims of the study are: 1) to assess the long-term effectiveness of CPAP therapy on neurocognitive function, mood, sleepiness, and quality of life by administering tests of these indices to subjects randomly assigned to active or sham CPAP; 2) to identify specific neurocognitive deficits associated with OSAS in a large, heterogeneous subject population; 3) to determine which deficits in neurocognitive function in OSAS subjects are reversible and most sensitive to the effects of CPAP; 4) to develop a composite multivariate outcome measure from the results of this study that can be used to assess the clinical effectiveness of CPAP in improving neurocognitive function, mood, sleepiness, and quality of life; and 5) to use functional magnetic resonance imaging to compare cortical activation before and after CPAP therapy, and to assess whether this change is associated with improvement in specific neurocognitive task performance. The primary endpoint of the study is the effect of six months of CPAP treatment on neurocognitive function. A total of 1100 subjects (550 per treatment group) will be enrolled from the patient populations at five sites (Stanford University; University of Arizona; Brigham and Women's Hospital; Massachusetts; St. Luke's Hospital, Missouri; St. Mary Medical Center, Washington).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CPAP | Active Comparator | Active Continuous Positive Airway Pressure (CPAP) |
|
| Sham CPAP | Placebo Comparator | Sham Continuous Positive Airway Pressure (CPAP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active CPAP | Device | Nightly nasal continuous positive airway pressure (CPAP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD | There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD) SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness). | 2 months and 6 months post intervention |
| Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL | There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL) | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
| Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR | There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR) |
| Measure | Description | Time Frame |
|---|---|---|
| Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT). These data are for variable #1: Pathfinder Number- Reaction Time (PN-RT) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) | Measured at diagnostic visit (baseline) and 6 months post intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William C. Dement, MD, PhD | Stanford University | Study Chair |
| Clete A. Kushida, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona AHSC | Tucson | Arizona | 85724 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17561541 | Background | Kushida CA, Nichols DA, Quan SF, Goodwin JL, White DP, Gottlieb DJ, Walsh JK, Schweitzer PK, Guilleminault C, Simon RD, Leary EB, Hyde PR, Holmes TH, Bloch DA, Green S, McEvoy LK, Gevins A, Dement WC. The Apnea Positive Pressure Long-term Efficacy Study (APPLES): rationale, design, methods, and procedures. J Clin Sleep Med. 2006 Jul 15;2(3):288-300. | |
| 22138103 | Background | Holmes TH, Nichols DA, Thomander D, Kushida CA. A method for estimating normative distributions for study-specific populations of clinical trials. Contemp Clin Trials. 2012 Mar;33(2):445-9. doi: 10.1016/j.cct.2011.11.014. Epub 2011 Nov 25. |
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Only in de-identified format to researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Active CPAP | Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA) |
| FG001 | Sham CPAP | Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active CPAP | Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA) |
| BG001 | Sham CPAP | Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD | There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD) SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness). | Analyses conducted in accordance with the intention-to-treat principle. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months and 6 months post intervention |
Adverse event data were collected from participant enrollment though the end of study visit (6 months). The APPLES Data and Safety Monitoring Board (DSMB) indicated events should be reported by body systems/event categories; data are reported this way.
All Serious Adverse Events (SAEs) and Adverse Events (AEs) were categorized into 17 body systems/event categories. Safety data were reviewed regularly by the APPLES DSMB; three categories were deemed most important for SAEs: Cardiovascular, MVA, and Death. Analyses were performed on post-randomization events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active CPAP | Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment |
There are study sample limitations because although participants with severe OSA were included, those who had the lowest oxygen saturation, a history of sleepiness-related accidents, or major cardiovascular comorbidities were excluded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah A. Nichols | Stanford University | 208-908-7364 | dnichols@cableone.net |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Sham CPAP | Device | Sham CPAP machine will be used for participants in the placebo group. |
|
|
| Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
| 2 months and 6 months post intervention |
| Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT). These data are for variable #2: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT) | 2 months and 6 months post intervention |
| Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT). These data are for variable #3: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT) | 2 months and 6 months post intervention |
| Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. One of the selected variables came from the domain of Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec). | 2 months and 6 months post intervention |
| Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh. These data are for variable #1: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD) SWMT-BehMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the difference from baseline relative to measures of working memory (WM) task performance accuracy (percent correct) and mean and standard deviation of reaction time (milliseconds). High-load WM tasks receive twice the weight of the low-load WM tasks. | 2 months and 6 months post intervention |
| Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh. These data are for variable #2: SWMT- Mid-day Activation Index (SWMT-ActMD) SWMT-ActMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline (BL) using standard deviation units. It is computed as the difference from BL relative to EEG power spectral variables (decibels) measured during the easier vs. more difficult working memory (WM) tasks. A positive activation sub-score indicates a larger cortical neuronal population was recruited to perform the more difficult WM task relative to BL, while a negative score indicates a smaller population was recruited. | 2 months and 6 months post intervention |
| Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD), SWMT- Mid-day Activation Index (SWMT-ActMD), and Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh). These data are for variable #3: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh) | 2 months and 6 months post intervention |
| Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL) | Objective sleepiness/alertness was measured using the Maintenance of Wakefulness Test (MWT); the outcome variable was MWT Mean Sleep Latency (MWT-MSL). The MWT was administered using four twenty-minute trials where the participant was asked to sit in a chair, in a quiet and dimly lit room, with instructions to stay awake. Trials were performed at 10 AM, Noon, 2 PM and 4 PM. The mean sleep latency was calculated using the 4 trials from a given visit, and required that at least 3 of the 4 trials were performed and validated. | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
| Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS) | Subjective sleepiness/alertness was measured using the Epworth Sleepiness Scale (ESS); the outcome variable was ESS Total Score (ESS-TS). The ESS is a validated questionnaire (8 questions) that ask the chances of dozing off in specific situations. Summing the scores produces a scaled total score between 0 and 24, with higher numbers indicating more subjective sleepiness. The ESS was administered the evening before the polysomnogram (PSG), or overnight sleep study. Data reported here include questionnaires collected at the DX, 2M, and 6M visits. | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
| Mood | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
| Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS) | Quality of life was measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI), which is an interview-administered instrument with high internal consistency and reliability. The SAQLI was designed to assess components identified as important to patients including daily functioning, social interactions, emotional functioning, symptoms experienced, and treatment-related symptoms. Items are scored on a seven-point scale, averaged (taking into account treatment-related symptoms), to yield a composite score between 1 and 7, where higher scores represent better quality of life. | diagnostic visit (baseline) |
| Palo Alto |
| California |
| 94305 |
| United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02459 | United States |
| St. Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| St. Mary Medical Center | Walla Walla | Washington | 99362 | United States |
| 20619727 | Background | Gevins A, Smith ME, McEvoy LK, Ilan AB, Chan CS, Jiang A, Sam-Vargas L, Abraham G. A cognitive and neurophysiological test of change from an individual's baseline. Clin Neurophysiol. 2011 Jan;122(1):114-20. doi: 10.1016/j.clinph.2010.06.010. Epub 2010 Jul 8. |
| 21358847 | Result | Quan SF, Chan CS, Dement WC, Gevins A, Goodwin JL, Gottlieb DJ, Green S, Guilleminault C, Hirshkowitz M, Hyde PR, Kay GG, Leary EB, Nichols DA, Schweitzer PK, Simon RD, Walsh JK, Kushida CA. The association between obstructive sleep apnea and neurocognitive performance--the Apnea Positive Pressure Long-term Efficacy Study (APPLES). Sleep. 2011 Mar 1;34(3):303-314B. doi: 10.1093/sleep/34.3.303. |
| 23204602 | Result | Kushida CA, Nichols DA, Holmes TH, Quan SF, Walsh JK, Gottlieb DJ, Simon RD Jr, Guilleminault C, White DP, Goodwin JL, Schweitzer PK, Leary EB, Hyde PR, Hirshkowitz M, Green S, McEvoy LK, Chan C, Gevins A, Kay GG, Bloch DA, Crabtree T, Dement WC. Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES). Sleep. 2012 Dec 1;35(12):1593-602. doi: 10.5665/sleep.2226. |
| 18853696 | Result | Vasquez MM, Goodwin JL, Drescher AA, Smith TW, Quan SF. Associations of dietary intake and physical activity with sleep disordered breathing in the Apnea Positive Pressure Long-Term Efficacy Study (APPLES). J Clin Sleep Med. 2008 Oct 15;4(5):411-8. |
| 24127141 | Result | Quan SF, Budhiraja R, Clarke DP, Goodwin JL, Gottlieb DJ, Nichols DA, Simon RD, Smith TW, Walsh JK, Kushida CA. Impact of treatment with continuous positive airway pressure (CPAP) on weight in obstructive sleep apnea. J Clin Sleep Med. 2013 Oct 15;9(10):989-93. doi: 10.5664/jcsm.3064. |
| 24910546 | Result | Batool-Anwar S, Goodwin JL, Drescher AA, Baldwin CM, Simon RD, Smith TW, Quan SF. Impact of CPAP on activity patterns and diet in patients with obstructive sleep apnea (OSA). J Clin Sleep Med. 2014 May 15;10(5):465-72. doi: 10.5664/jcsm.3686. |
| 25232509 | Result | Quan SF, Budhiraja R, Batool-Anwar S, Gottlieb DJ, Eichling P, Patel S, Shen W, Walsh JK, Kushida CA. Lack of Impact of Mild Obstructive Sleep Apnea on Sleepiness, Mood and Quality of Life. Southwest J Pulm Crit Care. 2014;9(1):44-56. doi: 10.13175/swjpcc082-14. |
| 24634638 | Result | Quan SF, Budhiraja R, Clarke DP, Goodwin JL, Gottlieb DJ, Nichols DA, Simon RD, Smith TW, Walsh JK, Kushida CA, Phillips B. You still need more than CPAP for OSA patients to lose weight. J Clin Sleep Med. 2014 Mar 15;10(3):349. doi: 10.5664/jcsm.3552. No abstract available. |
| 24916094 | Result | Prilipko O, Huynh N, Thomason ME, Kushida CA, Guilleminault C. An fMRI study of cerebrovascular reactivity and perfusion in obstructive sleep apnea patients before and after CPAP treatment. Sleep Med. 2014 Aug;15(8):892-8. doi: 10.1016/j.sleep.2014.04.004. Epub 2014 May 4. |
| 24808886 | Result | Huynh NT, Prilipko O, Kushida CA, Guilleminault C. Volumetric Brain Morphometry Changes in Patients with Obstructive Sleep Apnea Syndrome: Effects of CPAP Treatment and Literature Review. Front Neurol. 2014 Apr 29;5:58. doi: 10.3389/fneur.2014.00058. eCollection 2014. |
| 23227139 | Result | Prilipko O, Huynh N, Schwartz S, Tantrakul V, Kushida C, Paiva T, Guilleminault C. The effects of CPAP treatment on task positive and default mode networks in obstructive sleep apnea patients: an fMRI study. PLoS One. 2012;7(12):e47433. doi: 10.1371/journal.pone.0047433. Epub 2012 Dec 5. |
| 21358846 | Result | Prilipko O, Huynh N, Schwartz S, Tantrakul V, Kim JH, Peralta AR, Kushida C, Paiva T, Guilleminault C. Task positive and default mode networks during a parametric working memory task in obstructive sleep apnea patients and healthy controls. Sleep. 2011 Mar 1;34(3):293-301A. doi: 10.1093/sleep/34.3.293. |
| 26518698 | Result | Budhiraja R, Kushida CA, Nichols DA, Walsh JK, Simon RD, Gottlieb DJ, Quan SF. Impact of Randomization, Clinic Visits, and Medical and Psychiatric Cormorbidities on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea. J Clin Sleep Med. 2016 Mar;12(3):333-41. doi: 10.5664/jcsm.5578. |
| 27242272 | Result | Batool-Anwar S, Goodwin JL, Kushida CA, Walsh JA, Simon RD, Nichols DA, Quan SF. Impact of continuous positive airway pressure (CPAP) on quality of life in patients with obstructive sleep apnea (OSA). J Sleep Res. 2016 Dec;25(6):731-738. doi: 10.1111/jsr.12430. Epub 2016 May 30. |
| 42219794 | Derived | Liao J, Shi Y, Zhang B, Lv M, Li Y, Han D. Blood Pressure Trajectories and Cardiovascular Risk in Obstructive Sleep Apnea: A Dual-Cohort Analysis. J Sleep Res. 2026 May 31:e70366. doi: 10.1111/jsr.70366. Online ahead of print. |
| 39572221 | Derived | Zinchuk AV, Kushida CA, Walker A, Wellman A, Azarbarzin A, Alex RM, Varga AW, Sands SA, Yaggi HK. Arousal threshold modifies the effect of CPAP on executive function among individuals with obstructive sleep apnoea. Eur Respir J. 2025 Feb 13;65(2):2401183. doi: 10.1183/13993003.01183-2024. Print 2025 Feb. |
| 36917194 | Derived | Knauert MP, Adekolu O, Xu Z, Deng A, Chu JH, Baldassarri SR, Kushida C, Yaggi HK, Zinchuk A. Morning Chronotype Is Associated with Improved Adherence to Continuous Positive Airway Pressure among Individuals with Obstructive Sleep Apnea. Ann Am Thorac Soc. 2023 Aug;20(8):1182-1191. doi: 10.1513/AnnalsATS.202210-885OC. |
| 32190413 | Derived | Batool-Anwar S, Omobomi O, Quan SF. The effect of CPAP on HRQOL as measured by the Quality of Well-Being Self Administered Questionaire (QWB-SA). Southwest J Pulm Crit Care. 2020;20(1):29-40. doi: 10.13175/swjpcc070-19. |
| 28899524 | Derived | Holmes TH, Kushida CA. Adherence to continuous positive airway pressure improves attention/psychomotor function and sleepiness: a bias-reduction method with further assessment of APPLES. Sleep Med. 2017 Sep;37:130-134. doi: 10.1016/j.sleep.2017.06.022. Epub 2017 Jul 14. |
| Death |
|
| Excluded Pre-Randomization |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Active CPAP | Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA) |
| OG001 | Sham CPAP | Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device. |
|
|
|
| Primary | Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL | There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL) | Analyses conducted in accordance with the intention-to-treat principle. | Posted | Mean | 95% Confidence Interval | seconds | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
|
|
|
|
| Primary | Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR | There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR). This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR) | Analyses conducted in accordance with the intention-to-treat principle. | Posted | Mean | 95% Confidence Interval | number of words recalled | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
|
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|
|
| Secondary | Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT). These data are for variable #1: Pathfinder Number- Reaction Time (PN-RT) | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | seconds | 2 months and 6 months post intervention |
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| Secondary | Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT). These data are for variable #2: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT) | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | milliseconds | 2 months and 6 months post intervention |
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| Secondary | Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT). These data are for variable #3: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT) | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | milliseconds | 2 months and 6 months post intervention |
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| Secondary | Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. One of the selected variables came from the domain of Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec). | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | number of words recalled | 2 months and 6 months post intervention |
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| Secondary | Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh. These data are for variable #1: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD) SWMT-BehMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the difference from baseline relative to measures of working memory (WM) task performance accuracy (percent correct) and mean and standard deviation of reaction time (milliseconds). High-load WM tasks receive twice the weight of the low-load WM tasks. | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months and 6 months post intervention |
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| Secondary | Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh. These data are for variable #2: SWMT- Mid-day Activation Index (SWMT-ActMD) SWMT-ActMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline (BL) using standard deviation units. It is computed as the difference from BL relative to EEG power spectral variables (decibels) measured during the easier vs. more difficult working memory (WM) tasks. A positive activation sub-score indicates a larger cortical neuronal population was recruited to perform the more difficult WM task relative to BL, while a negative score indicates a smaller population was recruited. | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months and 6 months post intervention |
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| Secondary | Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh) | The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD), SWMT- Mid-day Activation Index (SWMT-ActMD), and Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh). These data are for variable #3: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh) | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | 95% Confidence Interval | number of rule changes (dichotomized) | 2 months and 6 months post intervention |
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| Secondary | Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL) | Objective sleepiness/alertness was measured using the Maintenance of Wakefulness Test (MWT); the outcome variable was MWT Mean Sleep Latency (MWT-MSL). The MWT was administered using four twenty-minute trials where the participant was asked to sit in a chair, in a quiet and dimly lit room, with instructions to stay awake. Trials were performed at 10 AM, Noon, 2 PM and 4 PM. The mean sleep latency was calculated using the 4 trials from a given visit, and required that at least 3 of the 4 trials were performed and validated. | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | Standard Deviation | minutes | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
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| Secondary | Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS) | Subjective sleepiness/alertness was measured using the Epworth Sleepiness Scale (ESS); the outcome variable was ESS Total Score (ESS-TS). The ESS is a validated questionnaire (8 questions) that ask the chances of dozing off in specific situations. Summing the scores produces a scaled total score between 0 and 24, with higher numbers indicating more subjective sleepiness. The ESS was administered the evening before the polysomnogram (PSG), or overnight sleep study. Data reported here include questionnaires collected at the DX, 2M, and 6M visits. | Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30). | Posted | Mean | Standard Deviation | scores on a scale | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
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| Secondary | Mood | Mood was dropped as a secondary outcome measure for analysis by our Core Team. | Posted | Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention |
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| Secondary | Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS) | Quality of life was measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI), which is an interview-administered instrument with high internal consistency and reliability. The SAQLI was designed to assess components identified as important to patients including daily functioning, social interactions, emotional functioning, symptoms experienced, and treatment-related symptoms. Items are scored on a seven-point scale, averaged (taking into account treatment-related symptoms), to yield a composite score between 1 and 7, where higher scores represent better quality of life. | Analyses performed for group of participants with SAQLI data. Baseline demographics were generally similar (mean age, sex ratio, proportion of white participants, average body mass index), and participants in both groups had similar SAQLI scores at baseline, which are presented below. | Posted | Mean | Standard Deviation | Units on a scale | diagnostic visit (baseline) |
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| Other Pre-specified | Functional Magnetic Resonance Imaging (fMRI) | fMRI was dropped as a secondary outcome measure for analysis by our Core Team. | Posted | Measured at diagnostic visit (baseline) and 6 months post intervention |
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| 32 |
| 556 |
| 390 |
| 556 |
| EG001 | Sham CPAP | Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device. | 31 | 542 | 373 | 542 |
| Motor Vehicle Accident (MVA) | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| General | General disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| GI / Digestive | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal / Digestive |
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| HEENT | General disorders | Systematic Assessment | Head, eyes, ears, nose, and throat |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Near-miss MVA | General disorders | Systematic Assessment | Near-miss Motor Vehicle Accident |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Other accident | General disorders | Systematic Assessment |
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| Psychiatric | Psychiatric disorders | Systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Motor Vehicle Accident (MVA) | General disorders | Systematic Assessment |
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| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Endocrinological | Endocrine disorders | Systematic Assessment |
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| General | General disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| GI / Digestive | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal / Digestive |
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| HEENT | General disorders | Systematic Assessment | Head, eyes, ears, nose, and throat |
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| Hematologic / Lymphatic | Immune system disorders | Systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Near-miss MVA | General disorders | Systematic Assessment | Near-miss Motor Vehicle Accident |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Psychiatric | Psychiatric disorders | Systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other Accident | General disorders | Systematic Assessment |
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| Work-related Accident | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| PFN-TOTL 6M |
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| Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL. Data were reciprocal transformed for analysis and back-transformed for reporting. | Parametric survival analysis | Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60. | 0.0860 | 2M A/P Function- PFN-TOTL; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses). | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL. Data were reciprocal transformed for analysis and back-transformed for reporting. | Parametric survival analysis | Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60. | 0.2103 | 6M A/P Function- PFN-TOTL; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses). | Superiority or Other |
| BSRT-SR 6M |
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Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR. |
| Regression, Linear |
Generalized Linear Models (GLM) were run by visit (2M and 6M). |
| 0.5444 |
2M L/M Function- BSRT-SR; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses). |
| Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.7569 | 6M L/M Function- BSRT-SR; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses). | Superiority or Other |
| 2M PN-RT Severe OSA |
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| 6M PN-RT Mild OSA |
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| 6M PN-RT Moderate OSA |
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| 6M PN-RT Severe OSA |
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| Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.6487 | 2M L/M Function- PN-RT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.5667 | 2M L/M Function- PN-RT (Severe OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.3972 | 6M L/M Function- PN-RT (Mild OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.3973 | 6M L/M Function- PN-RT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.3055 | 6M L/M Function- PN-RT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| 2M PVT-MedRT Severe OSA |
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| 6M PVT-MedRT Mild OSA |
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| 6M PVT-MedRT Moderate OSA |
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| 6M PVT-MedRT Severe OSA |
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| Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.9673 | 2M A/P Function- PVT-MedRT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.3426 | 2M A/P Function- PVT-MedRT (Severe OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.3901 | 6M A/P Function- PVT-MedRT (Mild OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.9464 | 6M A/P Function- PVT-MedRT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.4372 | 6M A/P Function- PVT-MedRT (Severe OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| 2M PVT-Slo10%RT Severe OSA |
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| 6M PVT-Slo10%RT Mild OSA |
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| 6M PVT-Slo10%RT Moderate OSA |
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| 6M PVT-Slo10%RT Severe OSA |
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| Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.6765 | 2M A/P Function- PVT-Slo10%RT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.5288 | 2M A/P Function- PVT-Slo10%RT (Severe OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.7807 | 6M A/P Function- PVT-Slo10%RT (Mild OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.9603 | 6M A/P Function- PVT-Slo10%RT (Moderate OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.3075 | 6M A/P Function- PVT-Slo10%RT (Severe OSA); P<0.05 indicates statistical significance for P values. Data were reciprocal transformed for analysis and back-transformed for reporting. | Superiority or Other |
| 2M BSRTDR-TotRec Severe OSA |
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| 6M BSRTDR-TotRec Mild OSA |
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| 6M BSRTDR-TotRec Moderate OSA |
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| 6M BSRTDR-TotRec Severe OSA |
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| Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.3161 | 2M L/M Function- BSRTDR-TotRec (Moderate OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.1835 | 2M L/M Function- BSRTDR-TotRec (Severe OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.2462 | 6M L/M Function- BSRTDR-TotRec (Mild OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.2069 | 6M L/M Function- BSRTDR-TotRec (Moderate OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.5235 | 6M L/M Function- BSRTDR-TotRec (Severe OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| 2M SWMT-BehMD Severe OSA |
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| 6M SWMT-BehMD Mild |
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| 6M SWMT-BehMD Moderate OSA |
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| 6M SWMT-BehMD Severe OSA |
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| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.8900 | 2M E/F Function- SWMT-BehMD (Moderate OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.0031 | 2M E/F Function- SWMT-BehMD (Severe OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.8703 | 6M E/F Function- SWMT-BehMD (Mild OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.1838 | 6M E/F Function- SWMT-BehMD (Moderate OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.0739 | 6M E/F Function- SWMT-BehMD (Severe OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| 2M SWMT-ActMD Severe OSA |
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| 6M SWMT-ActMD Mild |
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| 6M SWMT-ActMD Moderate OSA |
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| 6M SWMT-ActMD Severe OSA |
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| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.4512 | 2M E/F Function- SWMT-ActMD (Moderate OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.6672 | 2M E/F Function- SWMT-ActMD (Severe OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.8197 | 6M E/F Function- SWMT-ActMD (Mild OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.9890 | 6M E/F Function- SWMT-ActMD (Moderate OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Regression, Linear | Generalized Linear Models (GLM) were run by visit (2M and 6M). | 0.5029 | 6M E/F Function- SWMT-ActMD (Severe OSA); P<0.05 indicates statistical significance for P values. | Superiority or Other |
| 2M SAT-D-NumRuCh Severe OSA |
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| 6M SAT-D-NumRuCh Mild |
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| 6M SAT-D-NumRuCh Moderate OSA |
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| 6M SAT-D-NumRuCh Severe OSA |
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| Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.4108 | 2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.4528 | 2M E/F Function- SAT-D-NumRuCh (Severe OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.8391 | 6M E/F Function- SAT-D-NumRuCh (Mild OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.2771 | 6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion. | Superiority or Other |
| Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh. Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. | Mixed Models Analysis | Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M). | 0.8961 | 6M E/F Function- SAT-D-NumRuCh (Severe OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion. | Superiority or Other |
| DX MWT-MSL Moderate OSA |
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| DX MWT-MSL Severe OSA |
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| 2M MWT-MSL |
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| 2M MWT-MSL Mild OSA |
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| 2M MWT-MSL Moderate OSA |
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| 2M MWT-MSL Severe OSA |
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| 6M MWT-MSL |
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| 6M MWT-MSL Mild OSA |
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| 6M MWT-MSL Moderate OSA |
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| 6M MWT-MSL Severe OSA |
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Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL. |
| Chop-lump Wilcoxon |
Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. |
| 0.9778 |
DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. |
| Superiority or Other |
| Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.8314 | DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.5018 | DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.0052 | 2M- MWT-MSL; Comparison of means by visit only; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.2476 | 2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.7520 | 2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.0002 | 2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.0022 | 6M- MWT-MSL; Comparison of means by visit only; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.7630 | 6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.5170 | 6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL. | Chop-lump Wilcoxon | Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling. | 0.0002 | 6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| DX ESS-TS Moderate OSA |
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| DX ESS-TS Severe OSA |
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| 2M ESS-TS |
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| 2M ESS-TS Mild OSA |
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| 2M ESS-TS Moderate OSA |
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| 2M ESS-TS Severe OSA |
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| 6M ESS-TS |
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| 6M ESS-TS Mild OSA |
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| 6M ESS-TS Moderate OSA |
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| 6M ESS-TS Severe OSA |
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Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS. |
| Regression, Linear |
Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. |
| 0.6152 |
DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. |
| Superiority or Other |
| Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.7040 | DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.9537 | DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.0004 | 2M- ESS-TS; Comparison of means by visit only; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.3886 | 2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.0236 | 2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.0005 | 2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.0005 | 6M- ESS-TS; Comparison of means by visit only; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.3796 | 6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.0106 | 6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |
| Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS. | Regression, Linear | Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution. | 0.0010 | 6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values. | Superiority or Other |