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Home Sleep Apnea Testing for Cognitive Impairment (ENCHANT Trial)
N/A
Recruiting
Led By Mark I Boulos, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD), Probable AD dementia, Possible AD dementia due to limited concomitant cerebrovascular disease, Probable Vascular dementia or Vascular Mild Cognitive Impairment as per the 2011 American Heart Association Scientific Statement, Patients with a suspected neurodegenerative condition known to be associated with non-OSA sleep disorders (e.g. Parkinson's disease-related dementia and dementia with Lewy Bodies), Mixed disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
ENCHANT Trial Summary
This trial is investigating whether home sleep apnea testing is more effective than in-laboratory polysomnography in diagnosing obstructive sleep apnea in patients with vascular cognitive impairment or Alzheimer's disease.
Who is the study for?
This trial is for individuals with cognitive impairments like Mild Cognitive Impairment or Alzheimer's, and suspected sleep apnea. Participants should have certain cognitive scores (MoCA: 13-28, MMSE: 18-30, TorCA ≤281) and a caregiver if needed. It excludes those already on CPAP therapy for sleep apnea, with recent OSA diagnosis, severe lung/heart conditions affecting the test's accuracy, pacemakers or arrhythmias (for WatchPAT users), or significant physical/language barriers.Check my eligibility
What is being tested?
The study compares in-laboratory polysomnography (iPSG) to home sleep apnea testing (HSAT) to see which is better at completing sleep tests within six months in patients with vascular cognitive impairment and Alzheimer's disease. It also looks at cost-effectiveness, patient satisfaction, CPAP treatment rates, and changes in cognition and mood.See study design
What are the potential side effects?
There are generally minimal side effects associated with both iPSG and HSAT as they are diagnostic procedures rather than treatments. However discomfort from wearing the testing equipment during sleep may occur.
ENCHANT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of cognitive impairment or dementia, possibly due to Alzheimer's or vascular issues.
ENCHANT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who complete sleep testing
Secondary outcome measures
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
Cost to deliver each management strategy and treatment
+6 moreENCHANT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home Sleep Apnea TestExperimental Treatment1 Intervention
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
Group II: Standard of CareActive Control1 Intervention
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,108 Total Patients Enrolled
Unity Health TorontoOTHER
539 Previous Clinical Trials
447,565 Total Patients Enrolled
Mark I Boulos, MD, MScPrincipal InvestigatorUniversity of Toronto and Sunnybrook Health Sciences Centre
2 Previous Clinical Trials
440 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a type of cognitive impairment or dementia, possibly due to Alzheimer's or vascular issues.I was diagnosed with sleep apnea in the last 2 years.I can make my own medical decisions or have someone who can.I do not have severe lung or heart issues that could affect sleep study results.You are currently using a CPAP machine or a dental appliance for diagnosed sleep apnea.You have shown signs of problems with thinking and memory based on specific test scores.
Research Study Groups:
This trial has the following groups:- Group 1: Home Sleep Apnea Test
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial still ongoing?
"According to clinicaltrials.gov, this research initiative is not currently seeking out new participants at the present moment; it was initially posted on September 23rd 2019 and last edited on August 8th 2022. Subsequently, there are 1895 alternative trials actively recruiting patients right now."
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