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SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART)
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Standard of care
Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.
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Polysomnografie in het laboratorium van niveau 1 voor de detectie van obstructieve slaapapneu.
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Experimenteel: Portable sleep monitor (ApneaLink Air)
Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Proportion of patients diagnosed with treatable OSA
Tijdsspanne: 6 & 12 months
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Proportion of patients diagnosed with treatable OSA by 6 & 12 months
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6 & 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Kosten om elke managementstrategie en behandeling uit te voeren
Tijdsspanne: 6 maanden
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Kosten om elke managementstrategie en behandeling binnen 6 maanden uit te voeren
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6 maanden
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Proportion of patients prescribed CPAP for treatable OSA
Tijdsspanne: 6 & 12 months
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Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months
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6 & 12 months
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Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)
Tijdsspanne: 6 months
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Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
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6 months
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Daytime sleepiness (Epworth Sleepiness Scale)
Tijdsspanne: 6 & 12 months
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Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months
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6 & 12 months
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Neurological outcomes (as assessed by the Stroke Impact Scale)
Tijdsspanne: 6 months
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Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
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6 months
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Neurological outcomes (as assessed by the modified Rankin scale)
Tijdsspanne: 6 months
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Neurological outcomes (as assessed by the modified Rankin scale) at 6 months
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6 months
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Neurological outcomes (as assessed by the National Institutes of Health stroke scale)
Tijdsspanne: 6 months
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Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
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6 months
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24-hr ambulatory blood pressure
Tijdsspanne: 6 months
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24-hr ambulatory blood pressure at 6 months
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6 months
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New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)
Tijdsspanne: 12 months
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Assessed via telephone call at 12 months
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12 months
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Mark I Boulos, MD, MSc, Sunnybrook Research Institute
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Hart-en vaatziekten
- Vaatziekten
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Ziekten van de luchtwegen
- Ademhalingsstoornissen
- Slaapstoornissen, intrinsiek
- Dyssomnieën
- Slaap-waakstoornissen
- Tekenen en symptomen, ademhaling
- Ischemie van de hersenen
- Hartinfarct
- Slaapapneusyndromen
- Slaapapneu, obstructief
- Apneu
- Ischemische aanval, voorbijgaand
Andere studie-ID-nummers
- 116-2015
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Klinische onderzoeken op Polysomnografie in het laboratorium
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McGill University Health Centre/Research Institute...Northwestern UniversityWerving