Clinical trial NCT02454023: SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke
Official title: SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Obstructive Sleep Apnea
Keywords: Stroke
Transient ischemic attack
Obstructive sleep apnea
Portable sleep monitor
Screening
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2015-05-27
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients diagnosed with treatable OSA
timeFrame: 6 & 12 months
Secondary outcomes:
measure: Proportion of patients prescribed CPAP for treatable OSA
timeFrame: 6 & 12 months
measure: Cost to deliver each management strategy and treatment
timeFrame: 6 months
measure: Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)
timeFrame: 6 months
measure: Daytime sleepiness (Epworth Sleepiness Scale)
timeFrame: 6 & 12 months
measure: Neurological outcomes (as assessed by the Stroke Impact Scale)
timeFrame: 6 months
measure: Neurological outcomes (as assessed by the modified Rankin scale)
timeFrame: 6 months
measure: Neurological outcomes (as assessed by the National Institutes of Health stroke scale)
timeFrame: 6 months
measure: 24-hr ambulatory blood pressure
timeFrame: 6 months
measure: New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Mark I Boulos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boulos MI, Colelli DR, Vaccarino SR, Kamra M, Murray BJ, Swartz RH. Using a modified version of the "STOP-BANG" questionnaire and nocturnal oxygen desaturation to predict obstructive sleep apnea after stroke or TIA. Sleep Med. 2019 Apr;56:177-183. doi: 10.1016/j.sleep.2018.12.021. Epub 2019 Jan 7.
citation: Colelli DR, Kamra M, Rajendram P, Murray BJ, Boulos MI. Predictors of CPAP adherence following stroke and transient ischemic attack. Sleep Med. 2020 Feb;66:243-249. doi: 10.1016/j.sleep.2018.10.009. Epub 2018 Oct 24.
citation: Boulos MI, Kamra M, Colelli DR, Kirolos N, Gladstone DJ, Boyle K, Sundaram A, Hopyan JJ, Swartz RH, Mamdani M, Loong D, Isaranuwatchai W, Murray BJ, Thorpe KE. SLEAP SMART (Sleep Apnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke): A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):710-718. doi: 10.1161/STROKEAHA.120.033753. Epub 2021 Oct 11.
citation: MacDonald AA, Rajendram P, Kamra M, Murray BJ, MacDonald PA, Boulos MI. Predictors of in-laboratory polysomnography attendance in a cohort of patients with stroke or TIA. Sleep Med. 2020 Feb;66:159-164. doi: 10.1016/j.sleep.2019.10.002. Epub 2019 Oct 14.