The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Eligible age
55–85 yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this 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.
Sponsor: California Pacific Medical Center Research Institute
You may qualify if…
- ✓ 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 (EHR)
- ✓ 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
You may not qualify if…
- ✕ Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - a 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
- ✕ 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. (medical record/EHR). Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05988385 · last updated 2025-11-10