RecruitingNot applicable

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years, 24 months
  • Procedures mentioned: Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether treating obstructive sleep apnea (OSA), which causes breathing to stop and start during sleep, improves memory and signs linked to Alzheimer's disease. It is for adults ages 55–85 with normal memory and thinking and newly diagnosed moderate to severe OSA. Treatment starts right away or after a 3-month wait, with follow-up for 2 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 55–85 years old.
  • Have normal memory and thinking, with a score of at least 29 on the study's screening test.
  • Have moderate to severe OSA that meets the study's sleep test limits. Testing must be from the past 12 months or confirmed by a repeat test.
  • Are not being treated for OSA and have had no OSA treatment for at least 6 months.
  • Can and will receive OSA treatment if placed in the treatment group.
  • Speak English or Spanish fluently.

Who can't join

  • Have long-term insomnia, severe trouble falling asleep, a sleep-wake timing disorder, or another sleep-related breathing disorder; or use extra oxygen.
  • Have worked night shifts in the past 6 months, lack a regular place to sleep, or use cannabis or sleep medicines more than 2 nights a week.
  • Have uncontrolled mental illness diagnosed in the past 6 months, or a history of schizophrenia or bipolar disorder. Some well-controlled conditions are allowed.
  • Have a brain or nervous system disease, memory or thinking problems, recent delirium (sudden confusion), or another illness that affects thinking or prevents study completion.
  • Are pregnant or planning pregnancy, have weight-loss surgery planned within 3 months, or take certain weight-loss drugs and plan to lose at least 20 more pounds. The study doctor reviews weight-loss drug use.
  • Had a crash or near-miss due to sleepiness in the past year, or will work as a commercial driver, train engineer, or pilot during the study.
  • Use certain medicines, including antipsychotics, benzodiazepines, barbiturates, opioids, or anti-amyloid Alzheimer's treatments. Recently started or changing doses of memory drugs also exclude you. Methylphenidate for ADHD needs doctor review if the dose is stable.
  • Drink more than 14 alcoholic drinks a week. The study lists a possible exception for reducing drinking that began in the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (4)

AZ

  • University of Arizona · Tucson, AZ 85719Sairam Parsasarathy, MD · Principal investigatorMore trials in Tucson

NY

  • New York University · New York, NY 10016Acibiades Rodriguez, MD · Principal investigatorRicardo Osorio, MD · Principal investigatorMore trials in New York
  • Mount Sinai · New York, NY 10023Andrew Varga, MD · Principal investigatorJay Guevarra, MD · Principal investigatorMore trials in New York

PA