Status:
RECRUITING
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Obstructive Sleep Apnea
Alzheimer Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA), which causes abnormal pauses in breathing during sleep, is common in patients with vascular cognitive impairment (VCI) and Alzheimer's disease (AD), and exacerbates the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04335994
Start Date
September 23 2019
End Date
June 1 2027
Last Update
May 18 2025
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5