NCT06773416Not yet recruiting
CPAP Randomized Controlled Trial
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Alzheimer disease
- NCT number
- NCT06773416
What you commit to
- Study type: Interventional
- Planned participants: 206
- From Feb 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previously treated for sleep apnea
Other illness
- clinically significant insomnia (ISI \> 15), restless legs syndrome, or shift work
- taking disease modifying agents for MCI
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.