NCT05988385 The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
| NCT ID | NCT05988385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | California Pacific Medical Center Research Institute |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief 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.
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 (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 Exclusion Criteria: * 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 1