Improving cognitive outcomes in patients with sleep apnea using home testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.