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Obstructive sleep apnea (OSA) is common in older adults and has recently been implicated in pathogenesis of Alzheimer's disease (AD). Research has shown that sleep disruptions have caused memory impairment. Sleep apnea is a form of sleep disruption. We would like to examine how obstructive sleep apnea may contribute to the progression of Alzheimer's disease.
Aim 1: We will assess the endotypes (mechanisms) underlying OSA in elderly individuals known to be high risk for AD (vs. non-OSA matched controls) using novel recently validated simplified techniques which do not require burdensome complex overnight experiments to assess endotypes (primary outcome loop gain). We will further assess the predicted response to O2 therapy in terms of respiratory outcomes among elderly OSA patients with varying levels of loop gain and pharyngeal collapsibility.
Hypothesis 1: A substantial proportion of high AD risk patients with OSA should be O2 responsive as predicted using pathophysiological assessments.
Aim 2: We will perform an overnight mechanistic study of oxygen therapy vs. room air in high AD risk patients with OSA (recruited from Aim 1 and others if necessary). Given the frequent intolerance of PAP in elderly patients, we anticipate that oxygen therapy may be a viable therapeutic approach in this fragile population. We will focus on respiratory outcomes (primary outcome: apnea hypopnea index) but also assess sleep dependent memory consolidation on word pairs task given the major impact in the elderly.
Hypothesis 2: O2, compared to room air, will improve OSA and neurocognitive outcomes in select elderly OSA patients at risk of AD.
Aim 3: Preclinical AD with OSA and non-OSA controls, from Aim 1 will have structural and molecular brain imaging focusing on hippocampal atrophy as a predictor of memory consolidation. We will also assess amyloid and tau in the medial temporal region as function of OSA severity and as a predictor of neurocognitive function. This aim will lay the groundwork for designing a robust clinical trial using neuroimaging outcomes.
Hypothesis 3: Impairment in memory consolidation is a function of hippocampal size in OSA patients at risk of AD.
Aim 4: We will perform a pilot randomized trial of oxygen vs. PAP therapy in OSA patients with preclinical AD.
Hypothesis 4: In preclinical AD with OSA, oxygen will be a viable therapeutic strategy to improve memory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental Oxygen during PSG | Active Comparator | Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats >90% based on oximetry readings. |
|
| Room Air during PSG | Placebo Comparator | Subjects will be instrumented with a nasal cannula to receive 2L/min of pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats >90% based on oximetry readings. |
|
| Supplemental Oxygen for 3 Months | Experimental | Over a 12-week period, participants randomized to receive supplemental Oxygen for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring. |
|
| PAP Therapy for 3 Months | Experimental | Over a 12-week period, participants randomized to receive supplemental PAP therapy for treatment of OSA will be contacted weekly to be asked about their adherence. Participants' adherence will also be monitored remotely through cloud-based monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental Oxygen | Other | Subjects will be instrumented with a nasal cannula to receive 2L/min supplemental oxygen. The oxygen will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats >90% based on oximetry readings. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index - Crossover | The number of times a person stops breathing and periods of shallow breathing with a marked decrease in blood oxygen concentration every hour on average. A score lower than five indicates normal sleep (no sleep apnea), 5-15 indicates mild sleep apnea, 15-30 indicates moderate sleep apnea, and a score greater than 30 indicates severe sleep apnea. Result specified as change from room air condition to oxygen condition during the crossover trial | Over 8 hours on each of the two crossover treatment nights |
| Loop Gain (LG) - Crossover | A method used to measure respiratory stability of the negative feedback chemoreflex control system using a specialized Positive Airway Pressure machine called a pCrit. The overall loop gain of the ventilatory system reflects the ratio of the ventilatory response to the disturbance that elicited the response (LG = ventilatory response/ventilatory disturbance). The higher the loop gain, the potentially more unstable the respiratory control system becomes. Result specified as change from room air condition to oxygen condition during the crossover trial | Over 8 hours on each of the two crossover treatment nights |
| Neuroimaging - BRAAK12 tauPET | MRI and PET Scans. This study will examine pre-clinical Alzheimer's disease with OSA patients using brain imaging (structural MRI and amyloid/tau PET). MRI will be conducted to provide a structural image suitable for coregistering the PET image and observing white matter integrity. The scan should take 35 minutes. These will be MPRAGE images collected using the standard ADNI protocol at the in-house 3T MRI scanner at the University of California San Diego Altman Clinical and Translational Research Institute (ACTRI). The PET scan should take 70-90 minutes and uses the 18F-MK6240 tracer. Result given is the Standardized Uptake Value Ratio (SUVR) of tau protein in the BRAAK1-2 regions, the earliest regions to develop tau pathology in Alzheimer's disease | Two 1-hour long scans |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth Sleepiness Scale (ESS) - Parallel | A self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. Result specified as change from week 1 to week 12 during the parallel treatment trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Sleep Research | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40135690 | Result | Harding CD, Holloway BM, DeYoung PN, Kwan C, Djonlagic I, Ancoli-Israel S, Banks SJ, Malhotra A. Subjective daytime sleepiness, not sleep quality or hypoxia, predicts sleep-dependent memory consolidation in a cohort of older adults. J Clin Sleep Med. 2025 Jul 1;21(7):1217-1226. doi: 10.5664/jcsm.11648. | |
| 41025403 | Derived |
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182 participants were consented to take part in the study. 40 did not meet neurocogntive criteria. 40 did not have sleep apnea during their baseline sleep study, however, 10 of these participants were assigned to a control group for neuroanatomical scans. Of the remaining 112, 24 declined to take part in the randmoized trial following their baseline sleep study.
Participants were recruited from the University of California San Diego sleep clinic and via online advertisement across the San Diego area. Recruitment and enrollment occurred between October 8, 2021 and April 1, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-OSA Controls | Participants determined not to have obstructive sleep apnea based on their baseline sleep study. These individuals will not take part in randomized treatment trials but will be used as a healthy control group for neuroanatomical scan analyses. |
| FG001 | Crossover Only (Oxygen > Air) | This arm included participants who took part in the crossover treatment trial portion of the study only. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. |
| FG002 | Crossover Only (Air > Oxygen) | This arm included participants who took part in the crossover treatment trial portion of the study only. In the single-night crossover treatment trial, subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. |
| FG003 | Crossover (Oxygen > Air) and Parallel (Positive Airway Pressure) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. In the 12-week parallel treatment trial, subjects were instrumented to received positive airway pressure therapy automatically titrated between 4 cmH2O 20 cmH2O. |
| FG004 | Crossover (Oxygen > Air) and Parallel (Oxygen) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2L/min supplemental oxygen. |
| FG005 | Crossover (Air > Oxygen) and Parallel (Positive Airway Pressure) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. In the 12-week parallel treatment trial, subjects were instrumented to received PAP therapy automatically titrated between 4 cmH2O 20 cmH2O. |
| FG006 | Crossover (Air > Oxygen) and Parallel (Oxygen) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2L/min supplemental oxygen. |
| FG007 | Parallel Only (Positive Airway Pressure) | This arm included participants who took part in the parallel treatment trial portion of the study only. In the 12-week parallel treatment trial, subjects were instrumented to received positive airway pressure therapy automatically titrated between 4 cmH2O 20 cmH2O. |
| FG008 | Parallel Only (Oxygen) | This arm included participants who took part in the parallel treatment trial portion of the study only. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-OSA Controls | Participants determined not to have obstructive sleep apnea based on their baseline sleep study. These individuals will not take part in randomized treatment trials but will be used as a healthy control group for neuroanatomical scan analyses. |
| BG001 | Crossover Only (Oxygen > Air) |
| 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 - Crossover | The number of times a person stops breathing and periods of shallow breathing with a marked decrease in blood oxygen concentration every hour on average. A score lower than five indicates normal sleep (no sleep apnea), 5-15 indicates mild sleep apnea, 15-30 indicates moderate sleep apnea, and a score greater than 30 indicates severe sleep apnea. Result specified as change from room air condition to oxygen condition during the crossover trial | Only participants involved in the crossover portion of the trial were assessed for this Outcome Measure | Posted | Mean | Standard Deviation | units on a scale | Over 8 hours on each of the two crossover treatment nights |
|
from enrollment until end of follow-up, median duration 5 weeks
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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 | Non-OSA Controls | Participants determined not to have obstructive sleep apnea based on their baseline sleep study. These individuals will not take part in randomized treatment trials but will be used as a healthy control group for neuroanatomical scan analyses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Injury, poisoning and procedural complications | Non-systematic Assessment | Nasal cannula discomfort on oxygen night |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Atul Malhotra | University of California, San Diego | 8582462154 | sleepresearch@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2025 | Jul 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2024 | Nov 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D000544 | Alzheimer Disease |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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If subjects have been randomized to receive room air, subjects will have a nasal cannula with pressurized room air to avoid unblinding.
|
|
| Continuous Positive Airway Pressure Machine | Device | Continuous positive airway pressure is a form of positive airway pressure ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person. |
|
|
| Room Air | Other | Subjects will be instrumented with a nasal cannula to receive 2L/min pressurized room air. The room air will be kept at a fixed rate, however, the participant will be titrated to receive a max of 4 liters per min to maintain sats >90% based on oximetry readings. |
|
|
| 12 weeks |
| Pittsburgh Sleep Quality Index (PSQI) - Parallel | A 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Result specified as change from week 1 to week 12 during the parallel treatment trial | 12 weeks |
| Insomnia Severity Index (ISI) - Parallel | A 7-item self-report form to assess insomnia severity. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Result specified as change from week 1 to week 12 during the parallel treatment trial | 12 weeks |
| Holloway BM, Harding CD, DeYoung P, Kwan CG, Avetisyan L, Lui KK, Ancoli-Israel S, Banks SJ, Djonlagic I, Malhotra A. Comorbid insomnia and sleep apnea is associated with worse verbal episodic memory in older females. J Clin Sleep Med. 2025 Dec 1;21(12):2129-2138. doi: 10.5664/jcsm.11902. |
This arm included participants who took part in the crossover treatment trial portion of the study only. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. |
| BG002 | Crossover Only (Air > Oxygen) | This arm included participants who took part in the crossover treatment trial portion of the study only. In the single-night crossover treatment trial, subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. |
| BG003 | Crossover (Oxygen > Air) and Parallel (Positive Airway Pressure) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. In the 12-week parallel treatment trial, subjects were instrumented to received positive airway pressure therapy automatically titrated between 4 cmH2O 20 cmH2O. |
| BG004 | Crossover (Oxygen > Air) and Parallel (Oxygen) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2L/min supplemental oxygen. |
| BG005 | Crossover (Air > Oxygen) and Parallel (Positive Airway Pressure) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. In the 12-week parallel treatment trial, subjects were instrumented to received PAP therapy automatically titrated between 4 cmH2O 20 cmH2O. |
| BG006 | Crossover (Air > Oxygen) and Parallel (Oxygen) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2L/min supplemental oxygen. |
| BG007 | Parallel Only (Positive Airway Pressure) | This arm included participants who took part in the parallel treatment trial portion of the study only. In the 12-week parallel treatment trial, subjects were instrumented to received positive airway pressure therapy automatically titrated between 4 cmH2O 20 cmH2O. |
| BG008 | Parallel Only (Oxygen) | This arm included participants who took part in the parallel treatment trial portion of the study only. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline apnea-hypopnea index | The number of times a person stops breathing and periods of shallow breathing with a marked decrease in blood oxygen concentration every hour on average. A score lower than five indicates normal sleep (no sleep apnea), 5-15 indicates mild sleep apnea, 15-30 indicates moderate sleep apnea, and a score greater than 30 indicates severe sleep apnea. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Room Air |
Room air treatment night data for participants who took part in the crossover trial |
|
|
| Primary | Loop Gain (LG) - Crossover | A method used to measure respiratory stability of the negative feedback chemoreflex control system using a specialized Positive Airway Pressure machine called a pCrit. The overall loop gain of the ventilatory system reflects the ratio of the ventilatory response to the disturbance that elicited the response (LG = ventilatory response/ventilatory disturbance). The higher the loop gain, the potentially more unstable the respiratory control system becomes. Result specified as change from room air condition to oxygen condition during the crossover trial | Only participants involved in the crossover portion of the trial were assessed for this Outcome Measure | Posted | Mean | Standard Deviation | ratio | Over 8 hours on each of the two crossover treatment nights |
|
|
|
| Primary | Neuroimaging - BRAAK12 tauPET | MRI and PET Scans. This study will examine pre-clinical Alzheimer's disease with OSA patients using brain imaging (structural MRI and amyloid/tau PET). MRI will be conducted to provide a structural image suitable for coregistering the PET image and observing white matter integrity. The scan should take 35 minutes. These will be MPRAGE images collected using the standard ADNI protocol at the in-house 3T MRI scanner at the University of California San Diego Altman Clinical and Translational Research Institute (ACTRI). The PET scan should take 70-90 minutes and uses the 18F-MK6240 tracer. Result given is the Standardized Uptake Value Ratio (SUVR) of tau protein in the BRAAK1-2 regions, the earliest regions to develop tau pathology in Alzheimer's disease | Only a subsample of participants were scanned (n=20) for this portion of the trail which was independent of the treatment portion. Group 1 consists of enrolled individuals who were not randomized to treatment arms as they did not have OSA at baseline. Group 2 is a compound group consisting of participants with OSA at baseline and randomized to different treatment arms. | Posted | Mean | Standard Deviation | Standardized Uptake Value Ratio | Two 1-hour long scans |
|
|
|
| Secondary | Epworth Sleepiness Scale (ESS) - Parallel | A self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life. Result specified as change from week 1 to week 12 during the parallel treatment trial | Only participants involved in the parallel portion of the trial were assessed for this Outcome Measure | Posted | Mean | Standard Deviation | questionnaire sum score | 12 weeks |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) - Parallel | A 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. Result specified as change from week 1 to week 12 during the parallel treatment trial | Only participants involved in the parallel portion of the trial were assessed for this Outcome Measure | Posted | Mean | Standard Deviation | questionnaire sum score | 12 weeks |
|
|
|
| Secondary | Insomnia Severity Index (ISI) - Parallel | A 7-item self-report form to assess insomnia severity. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Result specified as change from week 1 to week 12 during the parallel treatment trial | Only participants involved in the parallel portion of the trial were assessed for this Outcome Measure | Posted | Mean | Standard Deviation | questionnaire sum score | 12 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Crossover Only (Oxygen > Air) | This arm included participants who took part in the crossover treatment trial portion of the study only. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. | 0 | 18 | 0 | 18 | 1 | 18 |
| EG002 | Crossover Only (Air > Oxygen) | This arm included participants who took part in the crossover treatment trial portion of the study only. In the single-night crossover treatment trial, subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Crossover (Oxygen > Air) and Parallel (Positive Airway Pressure) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. In the 12-week parallel treatment trial, subjects were instrumented to received positive airway pressure therapy automatically titrated between 4 cmH2O 20 cmH2O. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG004 | Crossover (Oxygen > Air) and Parallel (Oxygen) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen on the first night and room air on the second night. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2L/min supplemental oxygen. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG005 | Crossover (Air > Oxygen) and Parallel (Positive Airway Pressure) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. In the 12-week parallel treatment trial, subjects were instrumented to received PAP therapy automatically titrated between 4 cmH2O 20 cmH2O. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG006 | Crossover (Air > Oxygen) and Parallel (Oxygen) | This arm included participants who took part in both the crossover treatment trial and parallel treatment trial portions of the study. In the single-night crossover treatment trial, subjects subjects were instrumented with room air on the first night and a nasal cannula to receive 2 liters/min supplemental oxygen on the second night. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2L/min supplemental oxygen. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG007 | Parallel Only (Positive Airway Pressure) | This arm included participants who took part in the parallel treatment trial portion of the study only. In the 12-week parallel treatment trial, subjects were instrumented to received positive airway pressure therapy automatically titrated between 4 cmH2O 20 cmH2O. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG008 | Parallel Only (Oxygen) | This arm included participants who took part in the parallel treatment trial portion of the study only. In the 12-week parallel treatment trial, subjects were instrumented with a nasal cannula to receive 2 liters/min supplemental oxygen. | 0 | 5 | 0 | 5 | 0 | 5 |
|
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| D020920 |
| Dyssomnias |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |