Actively Recruiting
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
Led by Sunnybrook Health Sciences Centre · Updated on 2025-05-18
200
Participants Needed
1
Research Sites
401 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
U
Unity Health Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI/AD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI/AD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI/AD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.
CONDITIONS
Official Title
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Evidence of cognitive impairment shown by one of: Montreal Cognitive Assessment (MoCA) score of 13-28, Mini Mental State Examination (MMSE) score of 18-30, or Toronto Cognitive Assessment (TorCA) score 64281
- Diagnosis of one of the following: single-domain or multiple-domain mild cognitive impairment due to Alzheimer's disease, probable or possible Alzheimer's dementia, probable vascular dementia or vascular mild cognitive impairment, Parkinson's disease-related dementia, dementia with Lewy bodies, or mixed dementia
- Ability to provide informed consent or have a caregiver/substitute decision maker who can consent
- Availability of a caregiver to help with the home sleep apnea test or in-laboratory polysomnography if needed
You will not qualify if you...
- Prior diagnosis of obstructive sleep apnea within the last 2 years
- Current use of CPAP or dental appliance for obstructive sleep apnea
- Known contraindications for the home sleep apnea test, such as moderate to severe lung disease, congestive heart failure, permanent pacemaker, or certain heart arrhythmias
- Having any medical device that would interfere with the sleep apnea testing
- Significant physical impairment or language barrier that prevents using the home test or completing study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
M
Mark I Boulos, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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