An interventional study of In-laboratory polysomnography and Home Sleep Apnea Test in Obstructive Sleep Apnea, Alzheimer Disease and Vascular Dementia, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Diagnostic
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 cognitive deficits seen in these conditions. OSA is typically treated with continuous positive airway pressure (CPAP), which has been shown to improve cognition in VCI and slow cognitive decline in AD. Despite the need to identify OSA in patients with VCI/AD, these patients often do not undergo testing for OSA. One major barrier is that in-laboratory polysomnography (iPSG), the current standard for diagnosing OSA, is inconvenient for patients with VCI/AD who may be reliant on others for care or require familiar sleep environments. A convenient and cheaper alternative to iPSG is home sleep apnea testing (HSAT), which has been validated against iPSG to diagnose OSA and has proven feasible for use in VCI/AD. Our primary objective is to determine whether the use of HSAT is superior to iPSG in terms of the proportion of patients who complete sleep testing by 6 months post-randomization. We will also investigate cost-effectiveness, patient satisfaction, proportion of patients treated with CPAP, changes in cognition, mood, sleep-related and functional outcomes between HSAT and iPSG at 6 months.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 200 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive standard of care for diagnosing obstructive sleep apnea, which is in-laboratory polysomnography.
Device: In-laboratory polysomnography
Patients will undergo assessment for obstructive sleep apnea using a home sleep apnea test.
Device: Home Sleep Apnea Test
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
Also known as: iPSG
Use of a home sleep apnea test that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.
Also known as: HSAT
Proportion of patients who complete sleep testing
Proportion of patients who complete sleep testing by 6 months
Time frame: 6 months
Proportion of patients diagnosed with OSA and treated using CPAP
Proportion of patients diagnosed with OSA and treated using CPAP by 6 months
Time frame: 6 months
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment)
Cognitive Outcomes (as assessed by the Montreal Cognitive Assessment) at 6 months
Time frame: 6 months
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task)
Cognitive Outcomes (as assessed by the Psychomotor Vigilance Task) at 6 months
Time frame: 6 months
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire)
Sleep-related quality of life (as assessed by the Functional Outcomes of Sleep Questionnaire) at 6 months
Time frame: 6 months
Mood (as assessed by the Geriatric Depression Scale)
Mood (as assessed by the Geriatric Depression Scale) at 6 months
Time frame: 6 months
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale)
Daytime Sleepiness (as assessed by the Epworth Sleepiness Scale) at 6 months
Time frame: 6 months
Health Related Quality of Life (as assessed by the EQ-5D-5L)
Health Related Quality of Life (as assessed by the EQ-5D-5L) at 6 months
Time frame: 6 months
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale)
Patient satisfaction for each strategy and treatment (as assessed by a Likert scale) at 6 months
Time frame: 6 months
Cost to deliver each management strategy and treatment
Cost to deliver each management strategy and treatment by 6 months
Time frame: 6 months
Plan to share: No
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