SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART)
18. juni 2020 oppdatert av: Sunnybrook Health Sciences Centre
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Nivå 1 laboratoriepolysomnografi for påvisning av obstruktiv søvnapné.
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of patients diagnosed with treatable OSA
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Kostnad for å levere hver ledelsesstrategi og behandling
Tidsramme: 6 måneder
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Kostnad for å levere hver ledelsesstrategi og behandling innen 6 måneder
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6 måneder
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Proportion of patients prescribed CPAP for treatable OSA
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 12 months
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Assessed via telephone call at 12 months
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mark I Boulos, MD, MSc, Sunnybrook Research Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2015
Primær fullføring (Faktiske)
1. juli 2018
Studiet fullført (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først innsendt
19. mai 2015
Først innsendt som oppfylte QC-kriteriene
21. mai 2015
Først lagt ut (Anslag)
27. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvåkenforstyrrelser
- Tegn og symptomer, luftveier
- Hjerneiskemi
- Slag
- Søvnapné syndromer
- Søvnapné, obstruktiv
- Apné
- Iskemisk angrep, forbigående
Andre studie-ID-numre
- 116-2015
Plan for individuelle deltakerdata (IPD)
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UBESLUTTE
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