NCT02454023

SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Transient Ischemic Attack
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	In-laboratory polysomnography	Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-05-27
• Last updated: 2020-06-19

Locations

1 site across 1 country: Canada