SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial

Conditions
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Stroke, Transient Ischemic Attack, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Portable sleep monitor (ApneaLink Air)
* Device: In-laboratory polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging-confirmed stroke or stroke-neurologist diagnosed TIA in the past 6-months, and Outpatients being managed at the Sunnybrook Stroke Prevention clinic or inpatients on the Sunnybrook Stroke Unit. Exclusion Criteria: Prior diagnosis of OSA Current use of CPAP Life expectancy less than 12 months The presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure Oxygen therapy (eg. nasal prongs), a nasogastric tube, or other medical devices that would interfere with the placement of the sensors of the sleep monitoring device and/or CPAP Physical impairment, aphasia, or language barrier restricting ability to complete study assessments, overnight sleep monitoring, and/or comply with CPAP therapy, and no caregiver available to assist the patient with the study requirements Facial or bulbar weakness or trauma restricting the ability to create a seal with a CPAP mask Pregnancy Occupation that would make randomization to the standard of care arm unethical Not covered by Ontario health insurance plan (OHIP) Unable to attend follow-up assessments
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography. | Device: In-laboratory polysomnography<br>* Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.<br>|
| Experimental: Portable sleep monitor (ApneaLink Air)<br>Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor. | Device: Portable sleep monitor (ApneaLink Air)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients diagnosed with treatable OSA | Proportion of patients diagnosed with treatable OSA by 6 & 12 months | 6 & 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients prescribed CPAP for treatable OSA | Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months | 6 & 12 months | 
| Cost to deliver each management strategy and treatment | Cost to deliver each management strategy and treatment by 6 months | 6 months | 
| Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) | Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months | 6 months | 
| Daytime sleepiness (Epworth Sleepiness Scale) | Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months | 6 & 12 months | 
| Neurological outcomes (as assessed by the Stroke Impact Scale) | Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months | 6 months | 
| Neurological outcomes (as assessed by the modified Rankin scale) | Neurological outcomes (as assessed by the modified Rankin scale) at 6 months | 6 months | 
| Neurological outcomes (as assessed by the National Institutes of Health stroke scale) | Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months | 6 months | 
| 24-hr ambulatory blood pressure | 24-hr ambulatory blood pressure at 6 months | 6 months | 
| New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting) | Assessed via telephone call at 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Transient ischemic attack, Obstructive sleep apnea, Portable sleep monitor, Screening