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SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART)

18. juni 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Enhed: In-laboratorie polysomnografi
Niveau 1 laboratoriepolysomnografi til påvisning af obstruktiv søvnapnø.
Eksperimentel: Portable sleep monitor (ApneaLink Air)
Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
Enhed: Portable sleep monitor (ApneaLink Air)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients diagnosed with treatable OSA
Tidsramme: 6 & 12 months
Proportion of patients diagnosed with treatable OSA by 6 & 12 months
6 & 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Omkostninger til at levere hver ledelsesstrategi og behandling
Tidsramme: 6 måneder
Omkostninger til at levere hver ledelsesstrategi og behandling inden for 6 måneder
6 måneder
Proportion of patients prescribed CPAP for treatable OSA
Tidsramme: 6 & 12 months
Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months
6 & 12 months
Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)
Tidsramme: 6 months
Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
6 months
Daytime sleepiness (Epworth Sleepiness Scale)
Tidsramme: 6 & 12 months
Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months
6 & 12 months
Neurological outcomes (as assessed by the Stroke Impact Scale)
Tidsramme: 6 months
Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
6 months
Neurological outcomes (as assessed by the modified Rankin scale)
Tidsramme: 6 months
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)
Tidsramme: 6 months
Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
6 months
24-hr ambulatory blood pressure
Tidsramme: 6 months
24-hr ambulatory blood pressure at 6 months
6 months
New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)
Tidsramme: 12 months
Assessed via telephone call at 12 months
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sunnybrook Health Sciences Centre

Samarbejdspartnere

Unity Health Toronto

Efterforskere

  • Ledende efterforsker: Mark I Boulos, MD, MSc, Sunnybrook Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Faktiske)

1. juli 2018

Datoer for studieregistrering

Først indsendt

19. maj 2015

Først indsendt, der opfyldte QC-kriterier

21. maj 2015

Først opslået (Skøn)

27. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 116-2015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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