Sleep for Stroke Management and Recovery Trial
- Conditions
- StrokeRandomized Clinical TrialSleep ApneaMulticenter TrialIschemic StrokeCPAPHome Sleep Apnea TestSleep Apnea, ObstructiveTelemedicine
- Interventions
- Device: CPAP
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3062
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm: CPAP with Usual Care. CPAP 6 months of CPAP plus usual medical therapy.
- 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 (110)
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
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente Los Angeles
🇺🇸Los Angeles, California, United States
Doctors Medical Center of Modesto
🇺🇸Modesto, California, United States
UCLA Kaiser Fontana
🇺🇸Ontario, California, United States
UC Irvine
🇺🇸Orange, California, United States
Casa Colina
🇺🇸Pomona, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
UCSD Medical Center - Hillcrest Hospital
🇺🇸San Diego, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
🇺🇸San Francisco, California, United States
Orange County Global Medical Center
🇺🇸Santa Ana, California, United States
Olive View- UCLA Medical Center
🇺🇸Sylmar, California, United States
John Muir Medical Center- Walnut Creek Campus
🇺🇸Walnut Creek, California, United States
St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
UF Health Shands Hospital
🇺🇸Gainesville, Florida, United States
UF Jacksonville
🇺🇸Jacksonville, Florida, United States
Brooks Rehabilitation Hospital
🇺🇸Jacksonville, Florida, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Norton HealthCare
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center - Main Campus
🇺🇸New Orleans, Louisiana, United States
University Health Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Baystate Health
🇺🇸Springfield, Massachusetts, United States
UMass Memorial Medical Center,
🇺🇸Worcester, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
McLaren Flint
🇺🇸Flint, Michigan, United States
Trinity Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Mayo Clinic Saint Marys Campus
🇺🇸Rochester, Minnesota, United States
Saint Cloud/Centracare Health
🇺🇸Saint Cloud, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Cox Medical Center
🇺🇸Springfield, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
JFK Neuroscience Institute
🇺🇸Edison, New Jersey, United States
Hackensack Meridian Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
University of New Mexico Hospital
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
NYU Langone Brooklyn
🇺🇸Brooklyn, New York, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
NYU Langone -Tish Hospital Medical Center
🇺🇸New York, New York, United States
NYP Columbia University Medical Center
🇺🇸New York, New York, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Suny Upstate Medical University
🇺🇸Syracuse, New York, United States
Carolinas Medical Center Atrium Health
🇺🇸Charlotte, North Carolina, United States
Carolinas Rehab Northeast
🇺🇸Concord, North Carolina, United States
Guilford Neurologic Associates, Inc
🇺🇸Greensboro, North Carolina, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
UH Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
St. John Health System
🇺🇸Tulsa, Oklahoma, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
OSU Wexner Medical Center
🇺🇸Columbus, Ohio, United States
West Chester Hospital
🇺🇸West Chester, Ohio, United States
St. Luke's University Hospital Bethlehem Campus
🇺🇸Bethlehem, Pennsylvania, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
Penn State Milton S. Hershey Center
🇺🇸Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Palmetto Health Richland
🇺🇸Columbia, South Carolina, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Methodist University
🇺🇸Memphis, Tennessee, United States
Baylor Scott & White Institute of Rehabilitation
🇺🇸Dallas, Texas, United States
Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Utah Healthcare
🇺🇸Salt Lake City, Utah, United States
The University of Vermont Medical Center Main Campus
🇺🇸Burlington, Vermont, United States
UVA Medical Center
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax
🇺🇸Falls Church, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Ruby Memorial Hospital
🇺🇸Morgantown, West Virginia, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
University of Wisconsin University Hospital
🇺🇸Madison, Wisconsin, United States