The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study (NCT05988385) | Clinical Trial Compass
RecruitingNot Applicable
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
United States200 participantsStarted 2024-08-29
Plain-language 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 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.
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, substa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in overnight memory retention on the A-B verbal paired associates task
Timeframe: 3 months
2
Change in overnight memory retention on the A-B verbal paired associates task
Timeframe: 12 months
3
Change in overnight memory retention on the A-B verbal paired associates task
Timeframe: 24 months
4
Change in Aβ42/ Aβ40 ratio
Timeframe: 3 months
5
Change in Aβ42/ Aβ40 ratio
Timeframe: 24 months
6
Change in Plasma P-tau181
Timeframe: 3 months
7
Change in Plasma P-tau181
Timeframe: 24 months
8
Change in P-tau217
Trial details
NCT IDNCT05988385
SponsorCalifornia Pacific Medical Center Research Institute