Sleep for Stroke Management and Recovery Trial

Last updated: March 4, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Blood Clots

Thrombosis

Treatment

CPAP

Clinical Study ID

NCT03812653
HUM00147316
1U01NS099043-01A1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Current Inclusion Criteria, as of 6/28/2024:

  1. Ischemic stroke within the prior 7 days.

  2. NIH Stroke Scale Score ≥1 at the time of enrollment

Previous Inclusion Criteria, prior to 6/28/2024:

  1. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.

Exclusion Criteria (for entire time period):

  1. 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

Total Participants: 3062
Treatment Group(s): 1
Primary Treatment: CPAP
Phase:
Study Start date:
May 09, 2019
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • University of Alabama Hospital

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Chandler Regional Medical Center

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Banner University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Dignity Health - St. Joseph's Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Banner- University Medical Center Tucson

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • TMC Healthcare

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Mercy San Juan Medical Center

    Carmichael, California 95608
    United States

    Terminated

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Terminated

  • Community Regional Medical Center of Fresno

    Fresno, California 93701
    United States

    Site Not Available

  • Scripps Memorial

    La Jolla, California 92037
    United States

    Active - Recruiting

  • UCSD Health La Jolla

    La Jolla, California 92103
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Kaiser Permanente Los Angeles

    Los Angeles, California 94612
    United States

    Active - Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Doctors Medical Center of Modesto

    Modesto, California 95355
    United States

    Active - Recruiting

  • Hoag Memorial Hospital Presbyterian,

    Newport Beach, California 92663
    United States

    Site Not Available

  • UCLA Kaiser Fontana

    Ontario, California 91761
    United States

    Active - Recruiting

  • UC Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • Huntington Memorial Hospital

    Pasadena, California 91105
    United States

    Site Not Available

  • Casa Colina

    Pomona, California 91767
    United States

    Active - Recruiting

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California 92103
    United States

    Active - Recruiting

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Orange County Global Medical Center

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Olive View- UCLA Medical Center

    Sylmar, California 91342
    United States

    Site Not Available

  • John Muir Medical Center- Walnut Creek Campus

    Walnut Creek, California 94598
    United States

    Terminated

  • St. Mary's Hospital and Medical Center

    Grand Junction, Colorado 81501
    United States

    Active - Recruiting

  • Bridgeport Hospital

    Bridgeport, Connecticut 06610
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • Morton Plant Hospital

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • UF Health Shands Hospital

    Gainesville, Florida 32611
    United States

    Terminated

  • Brooks Rehabilitation Hospital

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • UF Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Baptist Hospital of Miami

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Jackson Memorial Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • St. Joseph's Hospital

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60513
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61603
    United States

    Terminated

  • Memorial Medical Center

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Central DuPage Hospital

    Winfield, Illinois 60190
    United States

    Site Not Available

  • St. Luke's Methodist Hospital

    Cedar Rapids, Iowa 52402
    United States

    Site Not Available

  • Genesis Medical Center West

    Davenport, Iowa 52803
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Mercy Medical Center- Sioux City

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St Elizabeth Healthcare NKY

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • University of Kentucky Albert B. Chandler Hospital

    Lexington, Kentucky 40526
    United States

    Site Not Available

  • Norton HealthCare

    Louisville, Kentucky 40218
    United States

    Active - Recruiting

  • Ochsner Medical Center - Main Campus

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • University Health Shreveport

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Eastern Maine Medical Center

    Bangor, Maine 04401
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Baystate Health

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • UMass Memorial Medical Center,

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Detroit Receiving Hospital

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • McLaren Flint

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • Mary Free Bed Rehabilitation Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Trinity Health Saint Mary's

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan 49008
    United States

    Active - Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic Saint Marys Campus

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Saint Cloud/Centracare Health

    Saint Cloud, Minnesota 56303
    United States

    Active - Recruiting

  • United Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Boone Hospital Center

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • SSM Health Saint Louis University Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Cox Medical Center

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Advanced Neurology Specialists

    Great Falls, Montana 59405
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • JFK Neuroscience Institute

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Hackensack Meridian Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Capital Health

    Trenton, New Jersey 08638
    United States

    Site Not Available

  • University of New Mexico Hospital

    Albuquerque, New Mexico 87106
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Active - Recruiting

  • NYU Langone Brooklyn

    Brooklyn, New York 11220
    United States

    Active - Recruiting

  • Buffalo General Medical Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • NYP Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYU Langone -Tish Hospital Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Strong Memorial Hospital

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Active - Recruiting

  • Suny Upstate Medical University

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Mission Hospital

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Carolinas Medical Center Atrium Health

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Carolinas Rehab Northeast

    Concord, North Carolina 28025
    United States

    Active - Recruiting

  • Guilford Neurologic Associates, Inc

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Sanford Medical Center

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Terminated

  • UH Cleveland Medical Center

    Cleveland, Ohio 11100
    United States

    Active - Recruiting

  • OSU Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Mercy Health Fairfield Hosptial

    Fairfield, Ohio 45014
    United States

    Site Not Available

  • Promedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • West Chester Hospital

    West Chester, Ohio 45069
    United States

    Active - Recruiting

  • St. John Health System

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Oregon Health & Science University Hospital

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvania 19090
    United States

    Site Not Available

  • St. Luke's University Hospital Bethlehem Campus

    Bethlehem, Pennsylvania 18015
    United States

    Active - Recruiting

  • Geisinger Clinic

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • Penn State Milton S. Hershey Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19122
    United States

    Active - Recruiting

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Palmetto Health Richland

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

  • Greenville Memorial Hospital

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Avera Research Institute

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Fort Sanders Regional Medical Center

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Methodist University

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • Baylor Scott & White Institute of Rehabilitation

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Valley Baptist Medical Center

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Memorial Hermann Texas Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Active - Recruiting

  • University of Utah Healthcare

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • The University of Vermont Medical Center Main Campus

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • UVA Medical Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Inova Fairfax

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Evergreen Health Medical Center Kirkland

    Kirkland, Washington 98034
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Terminated

  • Ruby Memorial Hospital

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin 54601
    United States

    Terminated

  • University of Wisconsin University Hospital

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

  • Marshfield Clinic Health System

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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