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Completed

NCT Number: NCT02454023

SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

In-laboratory polysomnography

Device

Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.

Primary outcomes

  1. Proportion of patients diagnosed with treatable OSA

    Time frame: 6 & 12 months

    Proportion of patients diagnosed with treatable OSA by 6 & 12 months

Secondary outcomes

  1. Proportion of patients prescribed CPAP for treatable OSA

    Time frame: 6 & 12 months

    Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months

  2. Cost to deliver each management strategy and treatment

    Time frame: 6 months

    Cost to deliver each management strategy and treatment by 6 months

  3. Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)

    Time frame: 6 months

    Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months

  4. Daytime sleepiness (Epworth Sleepiness Scale)

    Time frame: 6 & 12 months

    Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months

  5. Neurological outcomes (as assessed by the Stroke Impact Scale)

    Time frame: 6 months

    Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months

  6. Neurological outcomes (as assessed by the modified Rankin scale)

    Time frame: 6 months

    Neurological outcomes (as assessed by the modified Rankin scale) at 6 months

  7. Neurological outcomes (as assessed by the National Institutes of Health stroke scale)

    Time frame: 6 months

    Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months

  8. 24-hr ambulatory blood pressure

    Time frame: 6 months

    24-hr ambulatory blood pressure at 6 months

  9. New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)

    Time frame: 12 months

    Assessed via telephone call at 12 months

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Unity Health Toronto

Registry information

Official study title

SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial

Acronym: SLEAP SMART

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 27, 2015
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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