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).

Conditions

• Obstructive Sleep Apnea (OSA)
• Mild Cognitive Impairment (MCI)
• Cognitive Decline Prevention in Pre-frail Older Adults

Interventions

COMBINATION_PRODUCT

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

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.

COMBINATION_PRODUCT

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

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.

Sponsors & Collaborators

• Baycrest

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-28

Primary Completion

2027-09-30

Completion

2028-01-31

FDA Device

Yes

Countries

• Canada

Study Locations