The overall goal of this randomized controlled trial is to test the hypothesis that in older adults with mild cognitive impairment (MCI) and previously untreated obstructive sleep apnea (OSA), 4 months of web-based sleep education and continuous positive airway pressure (CPAP) will improve cognitive function more than web-based sleep education alone. Secondarily, this trial will test the hypothesis that 8 months of CPAP will improve cognitive function more than 4 months of CPAP. Moreover, treating OSA with CPAP can improve cognitive function and reduce Alzheimer's disease-related brain changes in older adults with MCI.
This study will compare an Early CPAP Group who will receive CPAP and sleep education simultaneously for 8 months upon enrollment to a Later CPAP Group who will first receive sleep education for 4 months followed by CPAP and sleep education for the next 4 months to test if early treatment is more beneficial.
Participants will:
1. Complete web-based sleep education modules through the Brain Health Pro (BHP) platform
2. Undergo CPAP therapy, including in-person mask fitting and regular monitoring alongside a study sleep technologist
At 0 months, 4 months, and 8 months, participants will participate in cognitive assessments, provide blood samples, use wearable devices to measure sleep patterns and physiology, and complete a 1-hr MRI (0 months and 4 months only).
Who can participate
Age range
55 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:
* 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.
Exclusion Criteria:
* 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 …
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.
1This trial is testing whether CPAP therapy might help slow cognitive decline in older adults with both obstructive sleep apnea and mild cognitive impairment — given that I may have one or both of these conditions, is my situation close enough to what this trial is looking for that it would be worth exploring further with my care team?
2The trial is not yet recruiting, so it could be months before it opens — given where I am right now with my sleep apnea and cognitive symptoms, should I be starting CPAP treatment now rather than waiting, and would starting treatment on my own affect my eligibility later?
3The primary outcome being measured is the Symbol Digit Modalities Test, which tracks a specific type of mental processing speed — can you help me understand what that test measures and whether it reflects the kinds of cognitive changes I or my family are most concerned about?
4Since this trial is listed as Phase NA, meaning it may be more of a behavioral or device study than a drug trial, what is already known about whether CPAP helps cognition in people with mild cognitive impairment, and how does enrolling in this study compare to just getting treated through standard care?
5The trial focuses on pre-frail older adults specifically — what does 'pre-frail' mean in this context, and is that a category my doctor thinks applies to me, since it could affect whether this study would even be relevant to discuss further?
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.