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

Recruiting

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Portable sleep monitor (ApneaLink Air) Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Portable sleep monitor (ApneaLink Air)
    Description: Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
  • In-laboratory polysomnography Device
    Intervention Desc: Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
    ARM 1: Kind: Experimental
    Label: Standard of care
    Description: Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Screening
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients diagnosed with treatable OSA 6 months No
Secondary Proportion of patients managed with CPAP for treatable OSA 6 & 12 months No
Secondary Cost to deliver each treatment 6 months No
Secondary Sleep-related quality of life (Functional Outcomes of Sleep Quality)questionnaire) 6 months No
Secondary Daytime sleepiness (Epworth Sleepiness Scale) 6 months No
Secondary Functional outcome (Functional Independence Measure) 6 months No
Secondary Ambulatory blood pressure 6 months No
Secondary New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting) 12 months No
Secondary Proportion of patients prescribed CPAP for treatable OSA 6 & 12 months
Secondary Proportion of patients compliant with CPAP therapy 6 & 12 months
Secondary Cost to deliver each management strategy and treatment 6 months
Secondary Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) 6 months
Secondary Neurological outcomes (as assessed by the Stroke Impact Scale) 6 months
Secondary Neurological outcomes (as assessed by the modified Rankin scale) 6 months
Secondary Neurological outcomes (as assessed by the National Institutes of Health stroke scale) 6 months
Secondary 24-hr ambulatory blood pressure 6 months

Sponsors