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SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART)

Primary Purpose

Stroke, Transient Ischemic Attack, Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Portable sleep monitor (ApneaLink Air)
In-laboratory polysomnography
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stroke focused on measuring Stroke, Transient ischemic attack, Obstructive sleep apnea, Portable sleep monitor, Screening

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Portable sleep monitor (ApneaLink Air)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 19, 2015
Last Updated
June 18, 2020
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02454023
Brief Title
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke
Acronym
SLEAP SMART
Official Title
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack, Obstructive Sleep Apnea
Keywords
Stroke, Transient ischemic attack, Obstructive sleep apnea, Portable sleep monitor, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.
Arm Title
Portable sleep monitor (ApneaLink Air)
Arm Type
Experimental
Arm Description
Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
Intervention Type
Device
Intervention Name(s)
Portable sleep monitor (ApneaLink Air)
Intervention Description
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
Intervention Name(s)
In-laboratory polysomnography
Intervention Description
Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
Primary Outcome Measure Information:
Title
Proportion of patients diagnosed with treatable OSA
Description
Proportion of patients diagnosed with treatable OSA by 6 & 12 months
Time Frame
6 & 12 months
Secondary Outcome Measure Information:
Title
Proportion of patients prescribed CPAP for treatable OSA
Description
Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months
Time Frame
6 & 12 months
Title
Cost to deliver each management strategy and treatment
Description
Cost to deliver each management strategy and treatment by 6 months
Time Frame
6 months
Title
Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)
Description
Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
Time Frame
6 months
Title
Daytime sleepiness (Epworth Sleepiness Scale)
Description
Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months
Time Frame
6 & 12 months
Title
Neurological outcomes (as assessed by the Stroke Impact Scale)
Description
Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
Time Frame
6 months
Title
Neurological outcomes (as assessed by the modified Rankin scale)
Description
Neurological outcomes (as assessed by the modified Rankin scale) at 6 months
Time Frame
6 months
Title
Neurological outcomes (as assessed by the National Institutes of Health stroke scale)
Description
Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
Time Frame
6 months
Title
24-hr ambulatory blood pressure
Description
24-hr ambulatory blood pressure at 6 months
Time Frame
6 months
Title
New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)
Description
Assessed via telephone call at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark I Boulos, MD, MSc
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30803829
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.
Results Reference
result
PubMed Identifier
30522873
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.
Results Reference
result
PubMed Identifier
34628939
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.
Results Reference
derived
PubMed Identifier
31877507
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.
Results Reference
derived

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SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

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