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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography. |
|
| Portable sleep monitor (ApneaLink Air) | Experimental | Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable sleep monitor (ApneaLink Air) | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark I Boulos, MD, MSc | Sunnybrook Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30803829 | Result | Boulos MI, Colelli DR, Vaccarino SR, Kamra M, Murray BJ, Swartz RH. Using a modified version of the "STOP-BANG" questionnaire and nocturnal oxygen desaturation to predict obstructive sleep apnea after stroke or TIA. Sleep Med. 2019 Apr;56:177-183. doi: 10.1016/j.sleep.2018.12.021. Epub 2019 Jan 7. | |
| 30522873 | Result |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| In-laboratory polysomnography | Device | Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea. |
|
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 |
| Colelli DR, Kamra M, Rajendram P, Murray BJ, Boulos MI. Predictors of CPAP adherence following stroke and transient ischemic attack. Sleep Med. 2020 Feb;66:243-249. doi: 10.1016/j.sleep.2018.10.009. Epub 2018 Oct 24. |
| 39901803 | Derived | Veitch MR, AlHamid MA, Muir RT, Dharmakulaseelan L, Ramirez JR, Gao F, Swartz RH, Murray BJ, Black SE, Boulos MI. Association between cerebral small vessel disease and periodic limb movements of sleep in patients with stroke/TIA. Sleep. 2025 Apr 11;48(4):zsaf027. doi: 10.1093/sleep/zsaf027. |
| 34628939 | Derived | Boulos MI, Kamra M, Colelli DR, Kirolos N, Gladstone DJ, Boyle K, Sundaram A, Hopyan JJ, Swartz RH, Mamdani M, Loong D, Isaranuwatchai W, Murray BJ, Thorpe KE. SLEAP SMART (Sleep Apnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke): A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):710-718. doi: 10.1161/STROKEAHA.120.033753. Epub 2021 Oct 11. |
| 31877507 | Derived | MacDonald AA, Rajendram P, Kamra M, Murray BJ, MacDonald PA, Boulos MI. Predictors of in-laboratory polysomnography attendance in a cohort of patients with stroke or TIA. Sleep Med. 2020 Feb;66:159-164. doi: 10.1016/j.sleep.2019.10.002. Epub 2019 Oct 14. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |