NCT06773416 · NOT YET RECRUITING
CPAP Randomized Controlled Trial
This trial tests whether using a CPAP machine (a mask that keeps airways open during sleep) plus online sleep education improves thinking and memory in older adults with mild cognitive impairment and untreated sleep apnea. One group starts CPAP right away, the other waits four months. It is not a drug phase, so there is no phase label.
You may qualify if
- Informed consent obtained and signed
- Age >55
- MCI: Participants will undergo a video-based screening, including a clinical interview, Logical Memory II, MoCA, and Lawton-Brody Instrumental Activities of Daily Living Scale Score. A participant will be considered to have MCI if they have: 1) MoCA score of 13-24 and Logical Memory II Score ≤ 8 (\&=16 years of education), ≤ 4 (8-15 years of education) or ≤ 2 (0-7 years of education) and Lawton-Brody IADL Score >14/23 and do not meet DSM IV criteria for dementia and have a change in self-perceived cognition from previous
- Moderate-severe OSA: Participants who screen positive for MCI will be mailed an at-home sleep apnea testing device. Participants with ODI≥5 will undergo in-lab polysomnography (PSG) for confirmation and characterization of sleep apnea. A participant will be considered to have moderate-severe OSA if they have on PSG: AHI>15, and ODI>10, and central apneas\<10% of all apneas, and periodic limb movement index \<15.
You're excluded if
- drowsiness-related driving accidents or near misses in the past 12 months
- drives as their primary occupation
- unable to complete cognitive evaluation in English
- unable to participate in video-based cognitive assessment
- not a resident of Ontario
- contraindications to MRI
- contraindications to CPAP or unwilling to start CPAP
- no available study partner to support CPAP
- previously treated for sleep apnea
- clinically significant insomnia (ISI > 15), restless legs syndrome, or shift work
- taking disease modifying agents for MCI
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-14