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OSA Treatment for Memory and Alzheimer's Biomarkers

This study, called ESSENTIAL, is looking at how treating obstructive sleep apnea (OSA) affects memory and markers linked to Alzheimer's disease in older adults. You might be able to join if you are between 55 and 85 years old, have moderate to severe OSA, and have normal thinking and memory skills. The study will compare different OSA treatments like positive airway pressure (PAP), oral appliance therapy, or positional therapy to a group that waits to receive treatment. Researchers will measure changes in your overnight memory retention at 3, 12, and 24 months to see if the treatments are successful. The goal is to enroll about 200 participants.

Study design
This is a randomized open-label trial, meaning participants are assigned to a treatment group by chance, and both you and the researchers will know which treatment you are receiving. It plans to enroll 200 participants.
What's involved
Participants will receive 3 months of OSA treatment or be in a waitlist control group. Your overnight memory retention will be measured at 3, 12, and 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after treatment to assess changes in memory.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05988385

The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study

Recruiting
NAAges 55–85InterventionalTreatment
California Pacific Medical Center Research Institute
~200 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Positive airway pressureOral appliance therapyPositional therapy

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in overnight memory retention on the A-B verbal paired associates task
Measured over 3 months
+13 more outcomes measured

Conditions

Obstructive Sleep Apnea
Cognitive Decline

Explore related trials

Alzheimer's DiseaseCognitive DysfunctionObstructive Sleep Apnea

Where it's being run

4 sites across 3 states
New York2
Arizona1
Pennsylvania1

Study leadership

  • 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

Who to contact

Lisa Takemori
[email protected]
415-633-6229
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

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
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.

What this trial measures

  • Change in overnight memory retention on the A-B verbal paired associates task3 months

    Mean change in percent correct memory

  • Change in overnight memory retention on the A-B verbal paired associates task12 months

    Mean change in percent correct memory

  • Change in overnight memory retention on the A-B verbal paired associates task24 months

    Mean change in percent correct memory

  • Change in Aβ42/ Aβ40 ratio3 months

    Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)

  • Change in Aβ42/ Aβ40 ratio24 months

    Mean change in the Aβ42/ Aβ40 ratio in picograms per millimeter (pg/ml)

  • Change in Plasma P-tau1813 months

    Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)

  • Change in Plasma P-tau18124 months

    Mean change in p-tau181 levels in the plasma in picograms per millimeter (pg/ml)

  • Change in P-tau2173 months

    Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)

  • Change in P-tau21724 months

    Mean change in p-tau217 levels in the plasma in picograms per millimeter (pg/ml)

  • Change in Neurofibrilary light (NfL)3 months

    Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)

  • Change in Neurofibrilary light (NfL)24 months

    Mean change in NfL levels in the plasma in picograms per millimeter (pg/ml)

  • Preclinical Cognitive Composite Score3 months

    Mean change in Preclinical Cognitive Composite Score.

  • Preclinical Cognitive Composite Score12 months

    Mean change in Preclinical Cognitive Composite Score.

  • Preclinical Cognitive Composite Score24 months

    Mean change in Preclinical Cognitive Composite Score.