Actively Recruiting
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)
Led by Sunnybrook Health Sciences Centre · Updated on 2025-05-18
200
Participants Needed
1
Research Sites
26 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
Researchers are investigating obstructive sleep apnea (OSA), a condition causing abnormal pauses in breathing during sleep that is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD). OSA worsens cognitive problems in these conditions, and although continuous positive airway pressure (CPAP) treatment has shown promise in improving cognition and slowing decline, many patients do not get tested due to the inconvenience of standard in-laboratory polysomnography (iPSG). This trial aims to find out if home sleep apnea testing (HSAT), a more convenient and less expensive option, leads to a higher rate of completed sleep tests within 6 months compared to iPSG. The study also examines cost-effectiveness, patient satisfaction, CPAP treatment rates, and changes in cognition, mood, sleep quality, and function between the two testing methods. Participants are randomly assigned to either the standard iPSG testing or the HSAT device, which records breathing and oxygen levels during sleep at home. Both groups receive usual care for diagnosing OSA. The study follows patients for 6 months after randomization to compare outcomes. HSAT measures respiratory effort, pulse, oxygen saturation, nasal flow, and reports apneas, hypopneas, snoring, and blood oxygen levels to detect OSA. The trial is a single-masked randomized controlled study. During the study, participants undergo sleep testing using their assigned method. Researchers assess how many complete the testing by 6 months as the primary outcome. They also evaluate cognitive function using the Montreal Cognitive Assessment and Psychomotor Vigilance Task, mood with the Geriatric Depression Scale, sleep quality with the Functional Outcomes of Sleep Questionnaire, daytime sleepiness using the Epworth Sleepiness Scale, and overall quality of life via the EQ-5D-5L. Patient satisfaction and cost of each testing strategy are also recorded. The total participation period is 6 months, during which caregivers may assist with completing the tests if needed.
CONDITIONS
Brief 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 with a Montreal Cognitive Assessment (MoCA) score of 13-28, or Mini Mental State Examination (MMSE) score of 18-30, or Toronto Cognitive Assessment (TorCA) score �381
- Diagnosis of mild cognitive impairment due to Alzheimer's disease or probable/possible Alzheimer's disease dementia
- Diagnosis of probable vascular dementia or vascular mild cognitive impairment
- Diagnosis of neurodegenerative conditions linked to non-OSA sleep disorders like Parkinson's disease-related dementia or dementia with Lewy Bodies
- Diagnosis of mixed dementia
- Ability to provide informed consent or have a substitute decision maker/caregiver consent
- Availability of a caregiver to assist with home sleep apnea testing 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 previously diagnosed obstructive sleep apnea
- Moderate to severe pulmonary disease or congestive heart failure that may affect home sleep apnea test results
- Presence of permanent pacemaker or history of sustained non-sinus cardiac arrhythmia if using certain home sleep apnea tests
- Any medical device interfering with home sleep apnea test placement
- Significant physical impairment or language barrier restricting use of home sleep apnea test or study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 1 day
Participants undergo sleep apnea testing using either in-laboratory polysomnography or a home sleep apnea test to detect obstructive sleep apnea.
1 visit (in-laboratory) or home assessment
Duration - 6 months
Participants are monitored for outcomes related to sleep apnea diagnosis, cognitive function, mood, sleep quality, and treatment adherence over 6 months.
Periodic assessments during 6 months
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
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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