Obstructive Sleep ApneaESSENTIALNCT05988385
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
A study testing Positive airway pressure, Oral appliance therapy and Positional therapy in people with Obstructive Sleep Apnea and Cognitive Decline, run by California Pacific Medical Center Research Institute at 4 sites in United States.
Trial summary
The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea, Cognitive Decline
- What is being tested?
- Positive airway pressure, Oral appliance therapy and Positional therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Aug 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognitively normal (TiCS ≥29)
- Age 55-85 years
- Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A>40/hr using a hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and/or EEG arousal (AHI3A), or equivalent based on in-home testing - Testing must have been completed in past 12 months or confirmed by repeat test
- Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
- Able and willing to be treated for OSA (Treatment group)
- Fluency in English or Spanish
Who cannot join
- Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form
- Documented diagnosis of circadian rhythm disorder
- Any current use of supplemental oxygen
- Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
- Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
- Anticipated scheduled bariatric surgery within the next 3 months
Show all 20Show fewer
- Chronic regular (> 2 nights per week) of cannabis for sleep
- Chronic regular use (> 2 nights per week) of sedatives/hypnotics for sleep
- Diagnosis of uncontrolled psychiatric disease in the last six months , and/or history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, generalized anxiety disorder, OCD, substance use disorders, and alcohol abuse/dependence. Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.
- Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine.
- Taking GLP-1 agonist semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound), or similar for weightloss, and planning to lose an additional 20lbs or more at the time of enrollment. PI Discretion for determination of why they are taking the drug based on conversation with subject and medical chart, will be documented in form of Note-to-file in the subject's records
- Presence of other comorbid condition that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or hematological conditions).
- Does not have a regular sleeping environment (i.e., sleeps in a different setting > 2 nights per week).
- Currently pregnant or planning to become pregnant.
- Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness > 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCI or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months.
- Near-miss or prior automobile accident "due to sleepiness" within the past 12 months.
- Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).
- Any use of neuroleptics, benzodiazepines, barbiturates, opiates or anti-amyloid therapies.
- Use of other cognitive enhancing drugs will also be excluded if initiated in the last 3 months, or not on stable dose.
- Consumption of >14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
New York University
New York, New York, 10016
Acibiades Rodriguez, MD
Ricardo Osorio, MD
- Recruiting
Mount Sinai
New York, New York, 10023
Andrew Varga, MD
Jay Guevarra, MD
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sanjay Patel, MD
- Recruiting
University of Arizona
Tucson, Arizona, 85719
Sairam Parsasarathy, MD
About this study
Official title: The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study
The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.
Read the detailed description
The prevalence of Alzheimer disease (AD) is high and projected to increase. While there are multiple risk factors for AD, epidemiological data suggests that ~15% of AD risk may be attributed to sleep problems. Obstructive sleep apnea (OSA) is common among the elderly (30-55%), and the investigators have shown that cognitively normal older women with OSA have nearly double the risk of developing mild cognitive impairment (MCI) or dementia over 5 years. Further, the investigators have shown that in normal elderly, OSA predicts longitudinal increases in AD biomarkers. Our preliminary data also show that after positive airway pressure (PAP) withdrawal, OSA patients treated with PAP experienced significant overnight increases in plasma neurofilament light (NfL), a marker of neural injury. The present study is designed to overcome challenges identified in previous trials of treatment of OSA to slow cognitive decline and progression to AD. First, the most effective treatment for OSA, PAP therapy, has poor adherence (typically only 50% are adequately treated). Other common therapies include oral appliance therapy (OAT) which tends to be better tolerated but less effective. The investigators have piloted and propose for this study a rapid multimodal therapy initiation (RMMT) which ensures subjects will have effective therapy for their OSA that reduces OSA severity to AHI4%<10/hour and AHI3A (AKA pRDI) < 20/hour within 4 months. Second, most prior OSA treatment trials have focused primarily on symptomatic older adults (e.g. patients with MCI recruited from memory clinics), whereas early intervention in pre-symptomatic individuals may have stronger impact in preventing progression to AD. The investigators propose to enroll cognitively normal adults with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). Finally, selection of cognitive outcomes most responsive to OSA therapy has proved challenging. The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults (MoCA≥24, Clinical Dementia Rating [CDR]=0), ages 55-75, recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers. Both arms will include PSG and actigraphy, sleep-dependent memory and other cognitive evaluations, and blood draws at baseline, 3 and 24 months, with cognitive evaluation only at 12 months. Structural brain MRI will be performed at baseline. Because the investigators anticipate that 150 of 200 subjects will be well treated at 24 months, and 50 will not be, the investigators will additionally recruit ~50 subjects (on average 13 subjects per clinical site) with the same inclusion criteria who refuse treatment. These 50 subjects will perform baseline (blood draw and cognitive evaluations), 12-month (cognitive evaluation only), and 24-month (blood draw and cognitive evaluations) visits, allowing for a 24-month comparison of ~150 subjects with adequate treatment over 24 months to 100 subjects with inadequate treatment over 24 months. Our aims are: 1) To compare 3-month change in plasma AD biomarkers (NfL, p-tau, Aβ) in those randomized to OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 2) To test differences at 3 months in sleep-dependent declarative memory and cognitive scores (PACC and sub-domains) between the OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 3) To compare 24-month changes in AD biomarkers (NfL, p-tau, Aβ) and cognition in all successfully treated subjects and untreated controls.
- Conditions
- Obstructive Sleep Apnea, Cognitive Decline
- Being tested
- Positive airway pressure, Oral appliance therapy, Positional therapy
- Keywords
- Obstructive Sleep Apnea, OSA, Cognitive decline, Alzheimer Disease, AD, AD biomarkers, Positive Airway Pressure, PAP, CPAP, Oral appliance therapy, OAT, Positional therapy, Sleep-dependent memory
- Medical subject headings
- Sleep Apnea, Obstructive, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive airway pressureDevice
Also called CPAP
Positive airway pressure (PAP) therapy is a sleep apnea treatment that uses a stream of compressed air to support the airway during sleep. With PAP therapy, a mask is worn during sleep and a portable machine gently blows pressurized room air from into your upper airway through a tube connected to the mask. This positive airflow helps keep the airway open, preventing the collapse that occurs during apnea, thus allowing normal breathing.
Oral appliance therapyDevice
Also called OAT, ProSomnus, Somnomed
Oral appliance therapy involves the use of a dental appliance or oral mandibular advancement device that prevents the tongue from blocking the throat and/or advances the lower jaw forward. These devices help keep the airway open during sleep.
Positional therapyDevice
Also called NightShift Sleep Positioner
A NightShift Sleep Positioner (Advanced Brain Monitoring) is a neck vibration device, FDA approved to treat positional sleep apnea. The device detects patient supine position and delivers a small vibratory signal to the back of the neck to prompt position change.
| Study group | Role | What they receive |
|---|---|---|
| 3-month OSA treatment | Active comparator | A 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a<15 (rapid multi-modal treatment RMMT). Receives: Device: Positive airway pressure; Device: Oral appliance therapy; Device: Positional therapy |
| Waitlist control group | Other | A waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Receives: Device: Positive airway pressure; Device: Oral appliance therapy; Device: Positional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overnight memory retention on the A-B verbal paired associates task
Mean change in percent correct memory
Measured: 3 months
Change in overnight memory retention on the A-B verbal paired associates task
Mean change in percent correct memory
Measured: 12 months
Change in overnight memory retention on the A-B verbal paired associates task
Mean change in percent correct memory
Measured: 24 months
Change in Aβ42/ Aβ40 ratio
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
Measured: 3 months
Change in Aβ42/ Aβ40 ratio
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
Measured: 24 months
Change in Plasma P-tau181
Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)
Measured: 3 months
Change in Plasma P-tau181
Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)
Measured: 24 months
Change in P-tau217
Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)
Measured: 3 months
Change in P-tau217
Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)
Measured: 24 months
Change in Neurofibrilary light (NfL)
Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)
Measured: 3 months
Change in Neurofibrilary light (NfL)
Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)
Measured: 24 months
Preclinical Cognitive Composite Score
Mean change in Preclinical Cognitive Composite Score.
Measured: 3 months
Preclinical Cognitive Composite Score
Mean change in Preclinical Cognitive Composite Score.
Measured: 12 months
Preclinical Cognitive Composite Score
Mean change in Preclinical Cognitive Composite Score.
Measured: 24 months
Secondary outcomes (12)
Change in Task-switching Accuracy
Change in Task-switching Mean Percent Accuracy
Measured: 3 months
Change in Task-switching Accuracy
Change in Task-switching Mean Percent Accuracy
Measured: 12 months
Change in Task-switching Accuracy
Change in Task-switching Mean Percent Accuracy
Measured: 24 months
Change in Task-switching Reaction Time
Change in Task-switching Mean Reaction Time in milliseconds
Measured: 3 months
Change in Task-switching Reaction Time
Change in Task-switching Mean Reaction Time in milliseconds
Measured: 12 months
Change in Task-switching Reaction Time
Change in Task-switching Mean Reaction Time in milliseconds
Measured: 24 months
Change in Psychomotor Vigilance Task (PVT) lapses
Mean change in number of lapses
Measured: 3 months
Change in Psychomotor Vigilance Task (PVT) lapses
Mean change in number of lapses
Measured: 12 months
Change in Psychomotor Vigilance Task (PVT) lapses
Mean change in number of lapses
Measured: 24 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Mean change in median reaction time in milliseconds.
Measured: 3 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Mean change in median reaction time in milliseconds.
Measured: 12 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Mean change in median reaction time in milliseconds.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start29 Aug 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 250 total patients (\~63 per site) will be enrolled. In the 3-month wait-list control randomized trial, 200 patients will be randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a\<15 (rapid multi-modal treatment RMMT); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. The remaining 50, plus an additional \~50 (n\~100 total) participants who declined treatment and were not interested in being randomized for the 3-month trial, or who have tried but failed treatment in the past, will serve as the "control" group for the 24-month follow-up period.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, New York University, University of Arizona, University of Pittsburgh, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Katie L Stone, PhD, Principal investigator, California Pacific Medical Center Research InstituteRicardo Osorio, MD, Principal investigator, New York UniversityAndrew Varga, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988385
- Sponsor's protocol ID
- AG080609
- Acronym
- ESSENTIAL
- Status last verified
- Aug 2026
- First submitted
- 22 May 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The final research data will be available in acceptable formats commonly accepted for documenting and supporting research findings. All data will be released and/or shared as soon as feasible without compromising privacy concerns, federal and state confidentiality concerns, proprietary interests, national security interests, or law enforcement activities. The final research data will not contain any patient identifiers. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study
- ClinicalTrials.gov ID
- NCT05988385
- Acronym / sponsor ID
- ESSENTIAL / AG080609
- Conditions
- Obstructive Sleep Apnea, Cognitive Decline
- Keywords
- Obstructive Sleep Apnea, OSA, Cognitive decline, Alzheimer Disease, AD, AD biomarkers, Positive Airway Pressure, PAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, New York University, University of Arizona, University of Pittsburgh, National Institute on Aging (NIA)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.
Detailed description
The prevalence of Alzheimer disease (AD) is high and projected to increase. While there are multiple risk factors for AD, epidemiological data suggests that ~15% of AD risk may be attributed to sleep problems. Obstructive sleep apnea (OSA) is common among the elderly (30-55%), and the investigators have shown that cognitively normal older women with OSA have nearly double the risk of developing mild cognitive impairment (MCI) or dementia over 5 years. Further, the investigators have shown that in normal elderly, OSA predicts longitudinal increases in AD biomarkers. Our preliminary data also show that after positive airway pressure (PAP) withdrawal, OSA patients treated with PAP experienced significant overnight increases in plasma neurofilament light (NfL), a marker of neural injury. The present study is designed to overcome challenges identified in previous trials of treatment of OSA to slow cognitive decline and progression to AD. First, the most effective treatment for OSA, PAP therapy, has poor adherence (typically only 50% are adequately treated). Other common therapies include oral appliance therapy (OAT) which tends to be better tolerated but less effective. The investigators have piloted and propose for this study a rapid multimodal therapy initiation (RMMT) which ensures subjects will have effective therapy for their OSA that reduces OSA severity to AHI4%<10/hour and AHI3A (AKA pRDI) < 20/hour within 4 months. Second, most prior OSA treatment trials have focused primarily on symptomatic older adults (e.g. patients with MCI recruited from memory clinics), whereas early intervention in pre-symptomatic individuals may have stronger impact in preventing progression to AD. The investigators propose to enroll cognitively normal adults with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). Finally, selection of cognitive outcomes most responsive to OSA therapy has proved challenging. The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults (MoCA≥24, Clinical Dementia Rating [CDR]=0), ages 55-75, recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA (AHI4% >20/hour or AHI3A > 40/hour). An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers. Both arms will include PSG and actigraphy, sleep-dependent memory and other cognitive evaluations, and blood draws at baseline, 3 and 24 months, with cognitive evaluation only at 12 months. Structural brain MRI will be performed at baseline. Because the investigators anticipate that 150 of 200 subjects will be well treated at 24 months, and 50 will not be, the investigators will additionally recruit ~50 subjects (on average 13 subjects per clinical site) with the same inclusion criteria who refuse treatment. These 50 subjects will perform baseline (blood draw and cognitive evaluations), 12-month (cognitive evaluation only), and 24-month (blood draw and cognitive evaluations) visits, allowing for a 24-month comparison of ~150 subjects with adequate treatment over 24 months to 100 subjects with inadequate treatment over 24 months. Our aims are: 1) To compare 3-month change in plasma AD biomarkers (NfL, p-tau, Aβ) in those randomized to OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 2) To test differences at 3 months in sleep-dependent declarative memory and cognitive scores (PACC and sub-domains) between the OSA treatment and wait-list control groups (via both intention-to-treat and per-protocol analyses); 3) To compare 24-month changes in AD biomarkers (NfL, p-tau, Aβ) and cognition in all successfully treated subjects and untreated controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 250 total patients (~63 per site) will be enrolled. In the 3-month wait-list control randomized trial, 200 patients will be randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a<15 (rapid multi-modal treatment RMMT); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. The remaining 50, plus an additional ~50 (n~100 total) participants who declined treatment and were not interested in being randomized for the 3-month trial, or who have tried but failed treatment in the past, will serve as the "control" group for the 24-month follow-up period.
| Arm | Type | Receives |
|---|---|---|
| 3-month OSA treatment | Active comparator | Device: Positive airway pressure, Device: Oral appliance therapy, Device: Positional therapyA 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI3a<15 (rapid multi-modal treatment RMMT). |
| Waitlist control group | Other | Device: Positive airway pressure, Device: Oral appliance therapy, Device: Positional therapyA waitlist control group to receive treatment at the conclusion of the 3-month intervention period. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cognitively normal (TiCS ≥29)
- Age 55-85 years
- Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A>40/hr using a hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and/or EEG arousal (AHI3A), or equivalent based on in-home testing - Testing must have been completed in past 12 months or confirmed by repeat test
- Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
- Able and willing to be treated for OSA (Treatment group)
Key exclusion criteria (20 listed)
- Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form
- Documented diagnosis of circadian rhythm disorder
- Any current use of supplemental oxygen
- Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
- Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
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 |
|---|---|---|
| Positive airway pressureAlso: CPAPPositive airway pressure (PAP) therapy is a sleep apnea treatment that uses a stream of compressed air to support the airway during sleep. With PAP therapy, a mask is worn during sleep and a portable machine gently blows pressurized room air from into your upper airway through a tube connected to the mask. This positive airflow helps keep the airway open, preventing the collapse that occurs during apnea, thus allowing normal breathing. | Device | 3-month OSA treatment, Waitlist control group |
| Oral appliance therapyAlso: OAT, ProSomnus, SomnomedOral appliance therapy involves the use of a dental appliance or oral mandibular advancement device that prevents the tongue from blocking the throat and/or advances the lower jaw forward. These devices help keep the airway open during sleep. | Device | 3-month OSA treatment, Waitlist control group |
| Positional therapyAlso: NightShift Sleep PositionerA NightShift Sleep Positioner (Advanced Brain Monitoring) is a neck vibration device, FDA approved to treat positional sleep apnea. The device detects patient supine position and delivers a small vibratory signal to the back of the neck to prompt position change. | Device | 3-month OSA treatment, Waitlist control group |
Primary outcome
Change in overnight memory retention on the A-B verbal paired associates task
Time frame: 3 months
Mean change in percent correct memory
Change in overnight memory retention on the A-B verbal paired associates task
Time frame: 12 months
Mean change in percent correct memory
Change in overnight memory retention on the A-B verbal paired associates task
Time frame: 24 months
Mean change in percent correct memory
Change in Aβ42/ Aβ40 ratio
Time frame: 3 months
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
Change in Aβ42/ Aβ40 ratio
Time frame: 24 months
Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)
Change in Plasma P-tau181
Time frame: 3 months
Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)
Change in Plasma P-tau181
Time frame: 24 months
Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)
Change in P-tau217
Time frame: 3 months
Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)
Change in P-tau217
Time frame: 24 months
Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)
Change in Neurofibrilary light (NfL)
Time frame: 3 months
Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)
Change in Neurofibrilary light (NfL)
Time frame: 24 months
Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)
Preclinical Cognitive Composite Score
Time frame: 3 months
Mean change in Preclinical Cognitive Composite Score.
Preclinical Cognitive Composite Score
Time frame: 12 months
Mean change in Preclinical Cognitive Composite Score.
Preclinical Cognitive Composite Score
Time frame: 24 months
Mean change in Preclinical Cognitive Composite Score.
12 secondary outcomes
Change in Task-switching Accuracy
Time frame: 3 months
Change in Task-switching Accuracy
Time frame: 12 months
Change in Task-switching Accuracy
Time frame: 24 months
Change in Task-switching Reaction Time
Time frame: 3 months
Change in Task-switching Reaction Time
Time frame: 12 months
Change in Task-switching Reaction Time
Time frame: 24 months
Change in Psychomotor Vigilance Task (PVT) lapses
Time frame: 3 months
Change in Psychomotor Vigilance Task (PVT) lapses
Time frame: 12 months
Change in Psychomotor Vigilance Task (PVT) lapses
Time frame: 24 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Time frame: 3 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Time frame: 12 months
Change in Psychomotor Vigilance Task (PVT) reaction time
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. The final research data will be available in acceptable formats commonly accepted for documenting and supporting research findings. All data will be released and/or shared as soon as feasible without compromising privacy concerns, federal and state confidentiality concerns, proprietary interests, national security interests, or law enforcement activities. The final research data will not contain any patient identifiers. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement.
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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.
Katie L Stone, PhD principal investigator
California Pacific Medical Center Research Institute
Ricardo Osorio, MD principal investigator
New York University
Andrew Varga, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive airway pressure, Oral appliance therapy and Positional therapy in people with Obstructive Sleep Apnea and Cognitive Decline, run by California Pacific Medical Center Research Institute at 4 sites 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 20 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Takemori (415-633-6229, lisa.takemori@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overnight memory retention on the A-B verbal paired associates task (time frame: 3 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.