Tests CPAP treatment for sleep apnea in older adults with mild cognitive impairment
Tests CPAP for sleep apnea in older adults with memory problems.
Plain-language title generated from the registry record
Registry title: CPAP Randomized Controlled Trial
Key facts
- Where
- Toronto, CanadaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults over 55 with mild cognitive impairment and moderate-to-severe sleep apnea who have never been treated for it. It tests CPAP plus sleep education.
- Age
- Over 55 years
- Sex
- All sexes can join.
- Disease stage
- Mild cognitive impairment (MCI), and moderate-to-severe obstructive sleep apnea confirmed by an in-lab sleep study (AHI>15, ODI>10).
- Earlier treatment
- People must not have been treated for sleep apnea before. People taking disease-modifying agents for MCI cannot join.
- Biomarker or test result
- Sleep study results: AHI>15, ODI>10, central apneas under 10% of all apneas, periodic limb movement index under 15. MCI is shown by MoCA score 13-24 and a low Logical Memory II score.
Main reasons for not taking part
- Drowsy-driving accidents or near misses in the past 12 months, or driving as a main job
- Not living in Ontario, or unable to do the cognitive tests in English or by video
- Contraindications to MRI or CPAP, or unwilling to start CPAP
- No study partner to support CPAP
- Clinically significant insomnia, restless legs syndrome, or shift work
Read by machine on 12 November 2026.
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaContact: Andrew Lim, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT06773416
- Record updated
- 14 January 2025
- Original description
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.Read full original descriptionShow less
Treating Sleep Apnea to Improve Cognitive Function, Alzheimer's Disease Pathology, and Astrocyte Activation in Older Adults With Cognitive Impairment: A Multi-Centre Randomized Controlled Trial
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).
Inclusion: 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: previously treated for sleep apnea; clinically significant insomnia (ISI > 15), restless legs syndrome, or shift work; taking disease modifying agents for MCI; 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.