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Vascular Dementia / Alzheimer Disease / In-laboratory polysomnography · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned randomized trial (not yet complete) comparing home sleep apnea testing versus in-laboratory polysomnography as a pathway to diagnose obstructive sleep apnea and initiate treatment in patients with cognitive impairment. The study aims to determine whether home testing improves test completion rates and downstream CPAP uptake, with secondary assessment of cognitive, mood, and functional outcomes. No results are reported in this registry record.
Interventional, Randomized, Parallel, Single masking, Diagnostic purpose. Obstructive Sleep Apnea, Alzheimer Disease, Vascular Dementia, Mild Cognitive Impairment, Parkinsons Disease With Dementia, Dementia With Lewy Bodies, Mixed De…. Intervention: Home Sleep Apnea Test. Compared with: Standard of Care — Active Comparator. n = 200. 1 site: Canada.
This is a planned randomized trial (not yet complete) comparing home sleep apnea testing versus in-laboratory polysomnography as a pathway to diagnose obstructive sleep apnea and initiate treatment in patients with cognitive impairment. The study aims to determine whether home testing improves test completion rates and downstream CPAP uptake, with secondary assessment of cognitive, mood, and functional outcomes. No results are reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results are pending and will inform whether home-based diagnostic testing can increase access to OSA diagnosis and CPAP treatment in cognitively impaired older adults, a population at high risk for diagnostic delays.
This is a trial registration with no results reported; it describes a planned interventional study comparing two diagnostic testing modalities in cognitively impaired patients, with completion and CPAP uptake as primary and secondary outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Results are pending and will inform whether home-based diagnostic testing can increase access to OSA diagnosis and CPAP treatment in cognitively impaired older adults, a population at high risk for diagnostic delays.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04335994). This is a study registration, not published results. Lead sponsor: Sunnybrook Health Sciences Centre. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Obstructive Sleep Apnea, Alzheimer Disease, Vascular Dementia, Mild Cognitive Impairment, Parkinsons Disease With Dementia, Dementia With Lewy Bodies, Mixed Dementia. Interventions: DEVICE: In-laboratory polysomnography; DEVICE: Home Sleep Apnea Test. Primary outcome measures: Proportion of patients who complete sleep testing , 6 months. 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 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.
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