SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

Not Applicable

Completed

• Conditions: Transient Ischemic Attack; Stroke; Obstructive Sleep Apnea
• Interventions: Device: In-laboratory polysomnography; Device: Portable sleep monitor (ApneaLink Air)

• Registration Number: NCT02454023
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Study Start: 2015-06
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	In-laboratory polysomnography	Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.
Portable sleep monitor (ApneaLink Air)	Portable sleep monitor (ApneaLink Air)	Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.

Primary Outcome Measures

Name	Time	Method
Proportion of patients diagnosed with treatable OSA	6 & 12 months	Proportion of patients diagnosed with treatable OSA by 6 \& 12 months

Secondary Outcome Measures

Name	Time	Method
Proportion of patients prescribed CPAP for treatable OSA	6 & 12 months	Proportion of patients prescribed CPAP for treatable OSA by 6 \& 12 months
Neurological outcomes (as assessed by the modified Rankin scale)	6 months	Neurological outcomes (as assessed by the modified Rankin scale) at 6 months
Cost to deliver each management strategy and treatment	6 months	Cost to deliver each management strategy and treatment by 6 months
Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)	6 months	Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
Daytime sleepiness (Epworth Sleepiness Scale)	6 & 12 months	Daytime sleepiness (Epworth Sleepiness Scale) at 6 \& 12 months
Neurological outcomes (as assessed by the National Institutes of Health stroke scale)	6 months	Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)	12 months	Assessed via telephone call at 12 months
Neurological outcomes (as assessed by the Stroke Impact Scale)	6 months	Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
24-hr ambulatory blood pressure	6 months	24-hr ambulatory blood pressure at 6 months

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada