SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-07-31

Brief Summary

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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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Detailed Description

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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

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Stroke Transient Ischemic Attack Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of care

Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.

Group Type ACTIVE_COMPARATOR

In-laboratory polysomnography

Intervention Type DEVICE

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

Portable sleep monitor (ApneaLink Air)

Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.

Group Type EXPERIMENTAL

Portable sleep monitor (ApneaLink Air)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

In-laboratory polysomnography

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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No