๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-01-08

CPAP Randomized Controlled Trial (NCT06773416)

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

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Sunnybrook Health Sciences Centre

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Sunnybrook Health Sciences Centre โ€” Toronto, Ontario

Age range: 55 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Sunnybrook Health Sciences Centre โ€” Toronto, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (416) 480-6100

Email: andrew.lim@sunnybrook.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—