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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,062
Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
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
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
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
Time frame: 6 months post randomization
Modified Rankin Scale Score
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).
Time frame: 3 months post randomization
NIH Stroke Score (NIHSS)
Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.
Time frame: 3 months post randomization
Short Montreal Cognitive Assessment (MoCA) Score
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.
Time frame: 3 months post randomization
Quality of Life outcome
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.
Time frame: 3 months post randomization
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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
...and 106 more locations