Could a home sleep test unlock better dementia care?
NCT ID NCT04335994
This trial is taking on new participants right now.
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial asks whether a home sleep apnea test can be a better first step than an overnight lab study for diagnosing obstructive sleep apnea in people with dementia or mild cognitive impairment. Sleep apnea is common in these conditions and can worsen thinking problems, but many patients never get tested because lab visits are difficult. The study will compare how many people complete testing within six months when offered a home test versus a lab test, and will also look at CPAP use, cognition, mood, and cost-effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Home Sleep Apnea Test (HSAT) compared to in-laboratory polysomnography (iPSG) for diagnosing obstructive sleep apnea
- What this could lead to
- If home testing proves more practical and equally reliable, it could make sleep apnea diagnosis easier for people with dementia, potentially improving cognitive outcomes through timely CPAP treatment.
- What could go wrong
- The trial is relatively small and focuses on completion rates rather than long-term cognitive benefits. Home tests may be less accurate than lab-based testing, and results may not apply to all dementia types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Jun 2027
An estimate. End dates often move.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N3M5, Canada
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