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Tests treatments for sleep apnea and their effect on memory in older adults

Tests sleep apnea treatments, including devices, in older adults with newly diagnosed moderate-severe sleep apnea.

Key facts

Who runs it
California Pacific Medical Center Research Institute
Where
New York, Pittsburgh, and Tucson, United StatesSee the 4 sites
Trial code
Registry title
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Status
Recruiting
People taking part
200 people, planned
Started
29 Aug 2024
Expected to end
31 May 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Positive airway pressure
  • Oral appliance therapy
  • Positional therapy
Record updated
26 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for older adults with normal thinking and memory who have newly found moderate to severe obstructive sleep apnea (OSA) and are not being treated for it.

Age
55 to 85 years
Sex
All sexes can join.
Disease stage
Moderate to severe obstructive sleep apnea, shown by a sleep test done in the past 12 months or confirmed by a repeat test. Thinking and memory must be normal (TiCS 29 or more).
Earlier treatment
Not on treatment for OSA now and no OSA treatment for at least 6 months.

Main reasons for not taking part

  • Chronic insomnia or a circadian rhythm disorder
  • Other sleep-related breathing disorders, such as central sleep apnea
  • Uncontrolled psychiatric disease in the last 6 months, or schizophrenia or bipolar disorder
  • Brain or nerve disease such as stroke, Parkinson's disease, Alzheimer's disease or epilepsy, or mild cognitive impairment
  • Currently pregnant or planning to become pregnant

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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 take part

  • Anticipated scheduled bariatric surgery within the next 3 months
  • 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
  • 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
  • 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
  • Documented diagnosis of circadian rhythm disorder
  • Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria
  • 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
  • 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)
  • 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
  • Any current use of supplemental oxygen
  • Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo
  • Chronic regular (> 2 nights per week) of cannabis for sleep
  • Chronic regular use (> 2 nights per week) of sedatives/hypnotics for sleep
  • Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine
  • 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
  • Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots)
  • Consumption of >14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 55 and 85 years old?

Where in United States

  • Mount SinaiNew York, United StatesContact: Andrew Varga, MD (principal investigator)Taking people
  • New York UniversityNew York, United StatesContact: Acibiades Rodriguez, MD (principal investigator)Taking people
  • University of PittsburghPittsburgh, United StatesContact: Sanjay Patel, MD (principal investigator)Taking people
  • University of ArizonaTucson, United StatesContact: Sairam Parsasarathy, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 3-month OSA treatmentExisting treatment, for comparison

    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).

    Treatment: Positive airway pressure, Oral appliance therapy, and Positional therapy

  • Waitlist control groupOther group

    A waitlist control group to receive treatment at the conclusion of the 3-month intervention period.

    Treatment: Positive airway pressure, Oral appliance therapy, and Positional therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study
Plain-language title
Tests treatments for sleep apnea and their effect on memory in older adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05988385, who can take part
Record updated
26 October 2026