Sleep for Stroke Management and Recovery Trial

Not Applicable

Recruiting

• Conditions: Stroke; Randomized Clinical Trial; Sleep Apnea; Multicenter Trial; Ischemic Stroke; CPAP; Home Sleep Apnea Test; Sleep Apnea, Obstructive; Telemedicine

• Registration Number: NCT03812653
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Detailed Description

Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Study Timeline

• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-23
• Study Start: 2019-05-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3062

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality	6 months post randomization	The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality
Modified Rankin Scale Score	3 months post randomization	Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).

Secondary Outcome Measures

Name	Time	Method
Short Montreal Cognitive Assessment (MoCA) Score	3 months post randomization	Cognitive outcome is measured by the Short MoCA. The short MoCA is a 5 minute short version of the Montreal Cognitive Assessment (MoCA). This instrument tests phonemic verbal fluency (1 point), delayed recall (5 points), and orientation (6 points) with a score ranging from 0-12.
NIH Stroke Score (NIHSS)	3 months post randomization	Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.
Quality of Life outcome	3 months post randomization	Quality of life outcome is measured by the shortened Stroke Specific Quality of Life Scale (SS-QOL). The short SS-QOL has 7 domains that include physical function, language, vision, thinking, energy, mood, and role function. There is 1 question from each domain. The 12 item SS-QOL is calculated by averaging the scores of these 12 questions.

Trial Locations

Locations (116)

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States

Chandler Regional Medical Center; 🇺🇸 Chandler, Arizona, United States

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States

Dignity Health - St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

TMC Healthcare; 🇺🇸 Tucson, Arizona, United States

Banner- University Medical Center Tucson; 🇺🇸 Tucson, Arizona, United States

Mercy San Juan Medical Center; 🇺🇸 Carmichael, California, United States

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Scripps Memorial; 🇺🇸 La Jolla, California, United States

UCSD Health La Jolla; 🇺🇸 La Jolla, California, United States

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