CPAP Randomized Controlled Trial

Summary

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).

Interventions

• CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health · COMBINATION_PRODUCT

  Participants in Group 1 will receive CPAP therapy immediately upon enrollment alongside web-based sleep education through the Brain Health Pro (BHP) platform. The CPAP intervention includes a study-provided auto-titrating device, in-person mask fitting, and ongoing support from a study sleep technologist. Adherence will be monitored via remote data uploads. The BHP platform is a 45-week web-based formal educational program program designed to increase dementia literacy, foster engagement, and convey best available evidence for lifestyle changes that can mitigate dementia risk. This combined approach ensures simultaneous initiation of CPAP and educational reinforcement to optimize adherence and cognitive outcomes.

• Delayed CPAP Therapy Combined with Web-Based Sleep Education for Cognitive and Sleep Health · COMBINATION_PRODUCT

  Participants in Group 2 will begin with 4 months of BHP web-based sleep education before adding CPAP therapy for the remaining 4 months. CPAP setup and support are identical to the Early CPAP group. Participants in Group 2 will experience procedure similar to current clinical practices.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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 \> 15), restless legs syndrome, or shift work
* taking disease modifying agents for MCI

Sites (1)

• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada