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StrokeSLEAP SMARTNCT02454023

SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

A study testing Portable sleep monitor (ApneaLink Air) and In-laboratory polysomnography in people with Stroke and Transient Ischemic Attack, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Portable sleep monitor (ApneaLink Air) and In-laboratory polysomnography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteCanada
Study dates
Jun 2015to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Portable sleep monitor (ApneaLink Air), In-laboratory polysomnography
Keywords
Stroke, Transient ischemic attack, Obstructive sleep apnea, Portable sleep monitor, Screening
Medical subject headings
Stroke, Ischemic Attack, Transient, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • In-laboratory polysomnographyDevice

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

Study groups in NCT02454023
Study groupRoleWhat they receive
Standard of careActive comparatorPatients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.
Receives: Device: In-laboratory polysomnography
Portable sleep monitor (ApneaLink Air)ExperimentalPatients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
Receives: Device: Portable sleep monitor (ApneaLink Air)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients diagnosed with treatable OSA

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

    Measured: 6 & 12 months

Secondary outcomes (9)

  1. Proportion of patients prescribed CPAP for treatable OSA

    Proportion of patients prescribed CPAP for treatable OSA by 6 \& 12 months

    Measured: 6 & 12 months

  2. Cost to deliver each management strategy and treatment

    Cost to deliver each management strategy and treatment by 6 months

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. Daytime sleepiness (Epworth Sleepiness Scale)

    Daytime sleepiness (Epworth Sleepiness Scale) at 6 \& 12 months

    Measured: 6 & 12 months

  5. Neurological outcomes (as assessed by the Stroke Impact Scale)

    Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months

    Measured: 6 months

  6. Neurological outcomes (as assessed by the modified Rankin scale)

    Neurological outcomes (as assessed by the modified Rankin scale) at 6 months

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. 24-hr ambulatory blood pressure

    24-hr ambulatory blood pressure at 6 months

    Measured: 6 months

  9. New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)

    Assessed via telephone call at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02454023
Sponsor's protocol ID
116-2015
Acronym
SLEAP SMART
Status last verified
Jun 2020
First submitted
19 May 2015
Last updated
19 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30803829

  • 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.

    PubMed 30522873

  • 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.

    PubMed 39901803

  • 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.

    PubMed 34628939

  • 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.

    PubMed 31877507

Questions about this trial

What is this clinical trial studying?

A study testing Portable sleep monitor (ApneaLink Air) and In-laboratory polysomnography in people with Stroke and Transient Ischemic Attack, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients diagnosed with treatable OSA (time frame: 6 & 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02454023, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.

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