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Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auto Aflex | Active Comparator | auto adjusting positive pressure therapy with AFLEX |
|
| Auto CPAP | Active Comparator | auto adjusting positive pressure therapy |
|
| CPAP | Active Comparator | continuous positive airway pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auto AFlex | Device | Positive pressure therapy treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index | The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days | Baseline and 180 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Average Hours of Nightly Use. | The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study. | 180 days |
| Psychomotor Vigilance Task - Number of Lapses |
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Inclusion Criteria:
Exclusion Criteria:
Participation in another interventional research study within the last 30 days
The need for more than one titration PSG (polysomnography)
The use of sedatives or hypnotics during the titration PSG
Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation < or equal to 88% for more than five minutes).
Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
Presence of untreated or poorly managed, non-OSAHS related sleep disorders:
Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
Consumption of ethanol more than 4 nights per week (CAGE criteria)
Shift workers
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| Name | Affiliation | Role |
|---|---|---|
| Clete A. Kushida, M.D.; Ph.D; | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15947324 | Background | Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085. | |
| 21804670 | Derived | Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, Kuna ST, Pegram GV Jr, Penzel T. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Sleep. 2011 Aug 1;34(8):1083-92. doi: 10.5665/SLEEP.1166. |
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168 participants were enrolled into the study. However 4 participants were excluded from the analysis and demographic data because they withdrew from the trial prior to any study procedures.
Patients who completed routine clinical diagnostic visit and CPAP titration polysomnography (PSG) at 5 international sleep centers were consecutively recruited for the study. These patients were approached with information on the study and were asked to consent to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Auto Aflex | auto adjusting positive pressure therapy with AFLEX Auto AFlex: Positive pressure therapy treatment |
| FG001 | Auto CPAP | auto adjusting positive pressure therapy Auto CPAP: Positive pressure therapy treatment |
| FG002 | CPAP | continuous positive airway pressure CPAP: Positive pressure therapy treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Auto Aflex | auto adjusting positive pressure therapy with AFLEX Auto AFlex: Positive pressure therapy treatment |
| BG001 | Auto CPAP | auto adjusting positive pressure therapy Auto CPAP: Positive pressure therapy treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Apnea-Hypopnea Index | The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | events/hour | Baseline and 180 Days |
|
6 months
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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 | Auto Aflex | auto adjusting positive pressure therapy with AFLEX Auto AFlex: Positive pressure therapy treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clete A. Kushida, MD, PhD | Stanford Sleep Medicine Center | (650) 721-7560 | clete@stanford.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Auto CPAP |
| Device |
Positive pressure therapy treatment |
|
| CPAP | Device | Positive pressure therapy treatment |
|
Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses.
Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms.
| Baseline and 180 Days |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired. | Baseline and 180 Days |
| Attitudes Toward Use | Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance. Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident. Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective. | Baseline and 180 Days |
| Subjective Assessment of Therapy Comfort. | visual analog scales where used to assess the question "in the last month how do you rate the overall comfort of the mask"? 0 = very uncomfortable to 100 = very comfortable | 30, 90, and 180 days |
| Epworth Sleepiness Scale | Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey. Scores are provided on a 0 to 3 scale: 0 = no chance of dozing
Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness. | Baseline and 180 days |
| Stanford |
| California |
| 94304 |
| United States |
| Gaylord Hospital | New Haven | Connecticut | 06472 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Charite Universitatsmedizin Berlin | Berlin | 10117 | Germany |
| BG002 | CPAP | continuous positive airway pressure CPAP: Positive pressure therapy treatment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Apnea-Hypopnea Index | The Apnea-Hypopnea Index is the average number of apneas and hypopneas per hour of sleep during the routine clinical diagnostic polysomnography visit. | Mean | Standard Deviation | events/hour |
|
auto adjusting positive pressure therapy
Auto CPAP: Positive pressure therapy treatment
| OG002 | CPAP | continuous positive airway pressure CPAP: Positive pressure therapy treatment |
|
|
|
| Secondary | Average Hours of Nightly Use. | The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study. | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | hours | 180 days |
|
|
|
| Secondary | Psychomotor Vigilance Task - Number of Lapses | Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms. | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | number of lapses | Baseline and 180 Days |
|
|
|
| Secondary | Functional Outcomes of Sleep Questionnaire (FOSQ) | FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired. | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 180 Days |
|
|
|
| Secondary | Attitudes Toward Use | Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance. Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident. Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective. | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 180 Days |
|
|
|
| Secondary | Subjective Assessment of Therapy Comfort. | visual analog scales where used to assess the question "in the last month how do you rate the overall comfort of the mask"? 0 = very uncomfortable to 100 = very comfortable | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | units on a scale | 30, 90, and 180 days |
|
|
|
| Secondary | Epworth Sleepiness Scale | Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey. Scores are provided on a 0 to 3 scale: 0 = no chance of dozing
Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness. | During the course of the study 24 participants withdrew from the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 180 days |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Auto CPAP | auto adjusting positive pressure therapy Auto CPAP: Positive pressure therapy treatment | 0 | 53 | 0 | 53 |
| EG002 | CPAP | continuous positive airway pressure CPAP: Positive pressure therapy treatment | 0 | 57 | 0 | 57 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| 180 days |
|
|
| 180 days |
|
|
| Confidence at 180 days |
|
|
| Expectations + Importance at baseline |
|
|
| Expectations + Importance at 180 days |
|
|
| 90 days |
|
|
| 180 days |
|
|
| 180 Days |
|
|