Sleep for Stroke Management and Recovery Trial
Purpose
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 or high risk TIA (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.
Conditions
- Ischemic Stroke
- Sleep Apnea
- Sleep Apnea, Obstructive
- TIA
- Stroke
- CPAP
- Telemedicine
- Home Sleep Apnea Test
- Randomized Clinical Trial
- Multicenter Trial
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.
Exclusion Criteria
- pre-event inability to perform all of own basic ADLs 2. unable to obtain informed consent from subject or legally authorized representative 3. incarcerated 4. known pregnancy 5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy 6. current use of positive airway pressure, or use within one month prior to stroke 7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible 8. severe bullous lung disease 9. history of prior spontaneous pneumothorax or current pneumothorax 10. hypotension requiring current treatment with pressors (can enroll later if this resolves) 11. other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP 12. massive epistaxis or previous history of massive epistaxis 13. cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus 14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure 15. current receipt of oxygen supplementation >4 liters per minute 16. current contact, droplet, respiratory/airborne precautions
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Eligible participants will be allocated in a 1:1 fashion to CPAP or no CPAP using a randomization method to protect subject treatment allocation and prevent potential selection biases.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Arm: CPAP with Usual Care. |
6 months of CPAP plus usual medical therapy. |
|
|
No Intervention Control Arm: Usual Care. |
6 months of usual medical therapy alone. |
|
Recruiting Locations
NYP Columbia University Medical Center
New York, New York 10032
New York, New York 10032
UH Cleveland Medical Center
Cleveland, Ohio 11100
Cleveland, Ohio 11100
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Guilford Neurologic Associates, Inc
Greensboro, North Carolina 27401
Greensboro, North Carolina 27401
Carolinas Rehab Northeast
Concord, North Carolina 28025
Concord, North Carolina 28025
Carolinas Medical Center Atrium Health
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Staten Island University Hospital
Staten Island, New York 10305
Staten Island, New York 10305
Strong Memorial Hospital
Rochester, New York 14642
Rochester, New York 14642
NYU Langone -Tish Hospital Medical Center
New York, New York 10016
New York, New York 10016
North Shore University Hospital
Manhasset, New York 11030
Manhasset, New York 11030
University of New Mexico Hospital
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Cox Medical Center
Springfield, Missouri 65807
Springfield, Missouri 65807
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Saint Cloud/Centracare Health
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Baylor Scott & White Institute of Rehabilitation
Dallas, Texas 75246
Dallas, Texas 75246
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Ruby Memorial Hospital
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
The University of Vermont Medical Center Main Campus
Burlington, Vermont 05401
Burlington, Vermont 05401
University of Utah Healthcare
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
Memorial Hermann Texas Medical Center
Houston, Texas 77030
Houston, Texas 77030
Avera Research Institute
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
Greenville Memorial Hospital
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Palmetto Health Richland
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Temple University Hospital
Philadelphia, Pennsylvania 19122
Philadelphia, Pennsylvania 19122
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Penn State Milton S. Hershey Center
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
St. Luke's University Hospital Bethlehem Campus
Bethlehem, Pennsylvania 18015
Bethlehem, Pennsylvania 18015
Providence St. Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Mayo Clinic Saint Marys Campus
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Chandler Regional Medical Center
Chandler, Arizona 85224
Chandler, Arizona 85224
Doctors Medical Center of Modesto
Modesto, California 95355
Modesto, California 95355
St. Mary's Hospital and Medical Center
Grand Junction, Colorado 81501
Grand Junction, Colorado 81501
John Muir Medical Center- Walnut Creek Campus
Walnut Creek, California 94598
Walnut Creek, California 94598
Orange County Global Medical Center
Santa Ana, California 92705
Santa Ana, California 92705
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California 94143
San Francisco, California 94143
UCSD Medical Center - Hillcrest Hospital
San Diego, California 92103
San Diego, California 92103
Kaiser Permanente Los Angeles
Los Angeles, California 94612
Los Angeles, California 94612
George Washington University Hospital
Washington, District of Columbia 20037
Washington, District of Columbia 20037
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
Los Angeles, California 90095
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Scripps Memorial
La Jolla, California 92037
La Jolla, California 92037
Rancho Los Amigos National Rehabilitation Center
Downey, California 90242
Downey, California 90242
Mercy San Juan Medical Center
Carmichael, California 95608
Carmichael, California 95608
Banner- University Medical Center Tucson
Tucson, Arizona 85719
Tucson, Arizona 85719
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
Phoenix, Arizona 85013
Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Yale-New Haven Hospital
New Haven, Connecticut 06510
New Haven, Connecticut 06510
UF Health Shands Hospital
Gainesville, Florida 32611
Gainesville, Florida 32611
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
University of Maryland
Baltimore, Maryland 21201
Baltimore, Maryland 21201
University Health Shreveport
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Ochsner Medical Center - Main Campus
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
OSF Saint Francis Medical Center
Peoria, Illinois 61603
Peoria, Illinois 61603
University of Chicago
Chicago, Illinois 60637
Chicago, Illinois 60637
University of Illinois Hospital and Health Sciences System
Chicago, Illinois 60612
Chicago, Illinois 60612
Sarasota Memorial Hospital
Sarasota, Florida 34239
Sarasota, Florida 34239
Brooks Rehabilitation Hospital
Jacksonville, Florida 32216
Jacksonville, Florida 32216
University of Wisconsin University Hospital
Madison, Wisconsin 53715
Madison, Wisconsin 53715
More Details
- NCT ID
- NCT03812653
- Status
- Recruiting
- Sponsor
- University of Michigan
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.