ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Apr 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how to better diagnose and treat obstructive sleep apnea (OSA) in patients who have cognitive impairments like Alzheimer's disease, vascular dementia, and other related conditions. OSA causes interruptions in breathing during sleep, which can worsen cognitive problems. The trial aims to compare two methods for testing sleep apnea: the traditional in-laboratory test and a more convenient home test. The goal is to see if the home test is easier for patients to complete and if it leads to better treatment outcomes, including improvements in thinking, mood, and overall well-being.

To be eligible for the trial, participants should have some level of cognitive impairment and a diagnosis related to Alzheimer's disease or vascular dementia. They must also be able to provide informed consent or have a caregiver who can assist. Throughout the trial, participants will complete sleep tests and may be treated with a device called CPAP, which helps keep the airway open during sleep. The study is currently recruiting participants and aims to make sleep apnea testing more accessible for those with cognitive challenges.

Gender

ALL

Eligibility 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.