NCT02454023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

3.1 years

First QC Date

May 19, 2015

Last Update Submit

June 18, 2020

Conditions

StrokeTransient Ischemic AttackObstructive Sleep Apnea

Keywords

StrokeTransient ischemic attackObstructive sleep apneaPortable sleep monitorScreening

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients diagnosed with treatable OSA

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

    6 & 12 months

Secondary Outcomes (9)

  • Proportion of patients prescribed CPAP for treatable OSA

    6 & 12 months

  • Cost to deliver each management strategy and treatment

    6 months

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

    6 months

  • Daytime sleepiness (Epworth Sleepiness Scale)

    6 & 12 months

  • Neurological outcomes (as assessed by the Stroke Impact Scale)

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Device: In-laboratory polysomnography

Portable sleep monitor (ApneaLink Air)

EXPERIMENTAL

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

Device: Portable sleep monitor (ApneaLink Air)

Interventions

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.

Portable sleep monitor (ApneaLink Air)
In-laboratory polysomnographyDEVICE

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

Standard of care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Related Publications (5)

  • 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.

    PMID: 30803829RESULT

  • 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.

    PMID: 30522873RESULT

  • Veitch MR, AlHamid MA, Muir RT, Dharmakulaseelan L, Ramirez JR, Gao F, Swartz RH, Murray BJ, Black SE, Boulos MI. Association between cerebral small vessel disease and periodic limb movements of sleep in patients with stroke/TIA. Sleep. 2025 Apr 11;48(4):zsaf027. doi: 10.1093/sleep/zsaf027.

    PMID: 39901803DERIVED

  • 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.

    PMID: 34628939DERIVED

  • 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.

    PMID: 31877507DERIVED

MeSH Terms

Conditions

StrokeIschemic Attack, TransientSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Mark I Boulos, MD, MSc

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 27, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 19, 2020

Record last verified: 2020-06

Locations

CA(1)