SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke

Stroke Clinical Trial

— SLEAP SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454023
• Other study ID #: 116-2015
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: July 2018

Study information

• Verified date: June 2020
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Ischemic Attack, Transient
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Transient Ischemic Attack

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients diagnosed with treatable OSA	Proportion of patients diagnosed with treatable OSA by 6 & 12 months	6 & 12 months
Secondary	Proportion of patients prescribed CPAP for treatable OSA	Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months	6 & 12 months
Secondary	Cost to deliver each management strategy and treatment	Cost to deliver each management strategy and treatment by 6 months	6 months
Secondary	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	6 months
Secondary	Daytime sleepiness (Epworth Sleepiness Scale)	Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months	6 & 12 months
Secondary	Neurological outcomes (as assessed by the Stroke Impact Scale)	Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months	6 months
Secondary	Neurological outcomes (as assessed by the modified Rankin scale)	Neurological outcomes (as assessed by the modified Rankin scale) at 6 months	6 months
Secondary	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	6 months
Secondary	24-hr ambulatory blood pressure	24-hr ambulatory blood pressure at 6 months	6 months
Secondary	New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)	Assessed via telephone call at 12 months	12 months