Improving cognitive outcomes in patients with sleep apnea using home testing
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing: A Randomized Controlled Trial (ENCHANT Study)
This study is trying to see if home testing for sleep apnea can help diagnose the condition better in people with cognitive issues like Alzheimer's, making it easier for them to get the treatment they need.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04335994 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of home sleep apnea testing (HSAT) compared to in-laboratory polysomnography (iPSG) in diagnosing obstructive sleep apnea (OSA) in patients with cognitive impairments such as Alzheimer's disease and vascular dementia. OSA is known to worsen cognitive deficits in these patients, yet many do not undergo necessary testing due to the inconvenience of iPSG. By utilizing HSAT, which is more accessible and comfortable, the study seeks to enhance the identification and treatment of OSA, potentially improving cognitive outcomes. The study will involve patients who meet specific cognitive impairment criteria and will assess the superiority of HSAT in diagnosing OSA.
Who should consider this trial
Good fit: Ideal candidates include individuals with cognitive impairment due to Alzheimer's disease, vascular dementia, or other neurodegenerative conditions who may also have obstructive sleep apnea.
Not a fit: Patients without cognitive impairment or those who do not have a diagnosis of obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for patients suffering from cognitive impairments associated with obstructive sleep apnea.
How similar studies have performed: Previous studies have shown that home sleep apnea testing is a feasible and effective alternative to in-laboratory testing for diagnosing obstructive sleep apnea in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE) score of 18-30, or (iii) Toronto Cognitive Assessment (TorCA) score ≤281. * A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD); or (ii) Probable AD dementia; or (iii) Possible AD dementia due to limited concomitant cerebrovascular disease; or (iv) Probable Vascular dementia or Vascular Mild Cognitive Impairment, as per the 2011 American Heart Association Scientific Statement; or (v) 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); and/or (vi) Mixed disease * Have the competency to provide informed consent, or the availability of a substitute decision maker/caregiver who can provide consent (if needed). * The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed. Exclusion Criteria: * Prior diagnosis of OSA within the last 2 years * Patients already using CPAP or a dental appliance for previously diagnosed OSA. * A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink); (b) Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT). * Any medical device that would interfere with the placement of the HSAT * Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments.
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mark I Boulos, MD, MSc — University of Toronto and Sunnybrook Health Sciences Centre
- Study coordinator: Mark I Boulos, MD, MSc
- Email: mark.boulos@sunnybrook.ca
- Phone: 4164804473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.