Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
NCT Number: NCT02454023
Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this study is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in sleep-related and functional outcomes.
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Interventional
Not applicable
Toronto, Ontario, Canada
Obstructive sleep apnea (OSA) is common after stroke and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. While in-laboratory polysomnography studies are the gold standard for diagnosing OSA, their use is limited by the lack of availability, patient unwillingness to sleep overnight at a laboratory and high costs. Home-based PSMs can accurately diagnose OSA and are much more accessible, convenient and low-priced compared to in-laboratory sleep studies.
The primary purpose of this study is to determine whether broad screening for OSA using PSMs, as compared to usual care, increases the proportion of patients diagnosed with treatable OSA after stroke or TIA. Secondary aims include whether screening with PSMs increases the proportion of patients treated for OSA with continuous positive airway pressure (CPAP) and whether functional outcomes and sleep-related outcomes are improved. Finally, the study will also determine whether this approach is cost-effective.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of a portable sleep monitor 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.
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
Time frame: 6 & 12 months
Proportion of patients diagnosed with treatable OSA by 6 & 12 months
Time frame: 6 & 12 months
Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months
Time frame: 6 months
Cost to deliver each management strategy and treatment by 6 months
Time frame: 6 months
Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
Time frame: 6 & 12 months
Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months
Time frame: 6 months
Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
Time frame: 6 months
Neurological outcomes (as assessed by the modified Rankin scale) at 6 months
Time frame: 6 months
Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
Time frame: 6 months
24-hr ambulatory blood pressure at 6 months
Time frame: 12 months
Assessed via telephone call at 12 months
Sunnybrook Health Sciences Centre
Other
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
Acronym: SLEAP SMART
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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