OSAPhase 1NCT05094271
Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
A Phase 1 study testing Supplemental Oxygen, Continuous Positive Airway Pressure Machine and Room Air in people with OSA and Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- OSA, Sleep Apnea, Obstructive Sleep Apnea
- What is being tested?
- Supplemental Oxygen, Continuous Positive Airway Pressure Machine and Room Air
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 12 Jun 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65-85 years
- Gender: Men or Women
- MOCA > 26
- Independently living and able to drive
- OSA (AHI ≥ 15/h) or no OSA
- Subjects must consent to waiving their right to obtain their PHS score (since the score is not yet actionable and could lead to social stress and ethical dilemmas)
Who cannot join
- Currently smoking
- History of COPD or asthma
- Heart Failure Class III or IV, unstable cardiovascular disease, or uncontrolled hypertension
- Neuromuscular Disease
- Drowsy Driving (ESS > 18/24)
- Inability to complete study procedures, such as questionnaire that are only available/validated in English
Show all 11Show fewer
- Lack of decisional capacity to provide informed consent
- Participants in whom magnetic resonance imaging Magnetic Resonance Imaging [MRI] is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant
- Presence of a brain tumor or lobar stroke
- Current drug or alcohol abuse/dependence
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- OSA, Sleep Apnea, Obstructive Sleep Apnea, Alzheimer Disease
- Being tested
- Supplemental Oxygen, Continuous Positive Airway Pressure Machine, Room Air
- Keywords
- sleep, OSA, Sleep Apnea, Obstructive Sleep Apnea, Alzheimer Disease, Sleep Disorder, Alzheimer
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Alzheimer Disease, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental OxygenOther
Also called Oxygen, O2
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.
Continuous Positive Airway Pressure MachineDevice
Also called CPAP, PAP
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 AirOther
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Supplemental Oxygen |
| 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. Receives: Other: Room Air |
| 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. Receives: Other: Supplemental Oxygen |
| 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. Receives: Device: Continuous Positive Airway Pressure Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Two 1-hour long scans
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start8 Oct 2021
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atul Malhotra, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094271
- Sponsor's protocol ID
- 200228
- Status last verified
- Mar 2026
- First submitted
- 22 Oct 2021
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40135690Holloway 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.
PubMed 41025403
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Obstructive Sleep Apnea Important in the Development of Alzheimer's Disease?
- ClinicalTrials.gov ID
- NCT05094271
- Acronym / sponsor ID
- 200228
- Conditions
- OSA, Sleep Apnea, Obstructive Sleep Apnea, Alzheimer Disease
- Keywords
- sleep, OSA, Sleep Apnea, Obstructive Sleep Apnea, Alzheimer Disease, Sleep Disorder, Alzheimer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supplemental Oxygen during PSG | Active comparator | Other: Supplemental OxygenSubjects 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 | Other: Room AirSubjects 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 | Other: Supplemental OxygenOver 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 | Device: Continuous Positive Airway Pressure MachineOver 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65-85 years
- Gender: Men or Women
- MOCA > 26
- Independently living and able to drive
- OSA (AHI ≥ 15/h) or no OSA
Key exclusion criteria (11 listed)
- Currently smoking
- History of COPD or asthma
- Heart Failure Class III or IV, unstable cardiovascular disease, or uncontrolled hypertension
- Neuromuscular Disease
- Drowsy Driving (ESS > 18/24)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplemental OxygenAlso: Oxygen, O2Subjects 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. | Other | Supplemental Oxygen during PSG, Supplemental Oxygen for 3 Months |
| Continuous Positive Airway Pressure MachineAlso: CPAP, PAPContinuous 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. | Device | PAP Therapy for 3 Months |
| Room AirAlso: PlaceboSubjects 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. | Other | Room Air during PSG |
Primary outcome
Apnea Hypopnea Index - Crossover
Time frame: Over 8 hours on each of the two crossover treatment nights
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
Loop Gain (LG) - Crossover
Time frame: Over 8 hours on each of the two crossover treatment nights
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
Neuroimaging - BRAAK12 tauPET
Time frame: Two 1-hour long scans
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
3 secondary outcomes
Epworth Sleepiness Scale (ESS) - Parallel
Time frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI) - Parallel
Time frame: 12 weeks
Insomnia Severity Index (ISI) - Parallel
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40135690Harding 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.
- Derived from this study: PubMed 41025403Holloway 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Supplemental Oxygen, Continuous Positive Airway Pressure Machine and Room Air in people with OSA and Sleep Apnea, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index - Crossover (time frame: Over 8 hours on each of the two crossover treatment nights). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.