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Procedure

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
Must not have
Known contraindication for the use of the HSAT that will be used in this study: Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink), Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of cognitive impairment or dementia, possibly due to Alzheimer's or vascular issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe lung or heart issues that could affect sleep study results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients who complete sleep testing
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,289 Total Patients Enrolled
Unity Health TorontoOTHER
556 Previous Clinical Trials
454,066 Total Patients Enrolled
Mark I Boulos, MD, MScPrincipal InvestigatorUniversity of Toronto and Sunnybrook Health Sciences Centre
2 Previous Clinical Trials
440 Total Patients Enrolled

Media Library

Home Sleep Apnea Test (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04335994 — N/A
Obstructive Sleep Apnea Research Study Groups: Home Sleep Apnea Test, Standard of Care
Obstructive Sleep Apnea Clinical Trial 2023: Home Sleep Apnea Test Highlights & Side Effects. Trial Name: NCT04335994 — N/A
Home Sleep Apnea Test (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335994 — N/A
~0 spots leftby Dec 2024
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