Sleep for Stroke Management and Recovery Trial

NCT ID: NCT03812653

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3062 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke Sleep Apnea Sleep Apnea, Obstructive Stroke CPAP Telemedicine Home Sleep Apnea Test Randomized Clinical Trial Multicenter Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Intervention Arm: CPAP with Usual Care.

6 months of CPAP plus usual medical therapy.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.

Control Arm: Usual Care.

6 months of usual medical therapy alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP

Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Ischemic stroke within the prior 7 days.
2. NIH Stroke Scale Score ≥1 at the time of enrollment


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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

FusionHealth LLC

UNKNOWN

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Devin L. Brown, MD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Devin Brown, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Ronald Chervin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Alabama Hospital

Birmingham, Alabama, United States

Site Status

Chandler Regional Medical Center

Chandler, Arizona, United States

Site Status

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Site Status

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

Phoenix, Arizona, United States

Site Status

TMC Healthcare

Tucson, Arizona, United States

Site Status

Banner- University Medical Center Tucson

Tucson, Arizona, United States

Site Status

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Site Status

Scripps Memorial

La Jolla, California, United States

Site Status

UCSD Health La Jolla

La Jolla, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente Los Angeles

Los Angeles, California, United States

Site Status

Doctors Medical Center of Modesto

Modesto, California, United States

Site Status

UCLA Kaiser Fontana

Ontario, California, United States

Site Status

UC Irvine

Orange, California, United States

Site Status

Casa Colina

Pomona, California, United States

Site Status

Kaiser Redwood

Redwood City, California, United States

Site Status

UC Davis Medical Center

Sacramento, California, United States

Site Status

UCSD Medical Center - Hillcrest Hospital

San Diego, California, United States

Site Status

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, United States

Site Status

Orange County Global Medical Center

Santa Ana, California, United States

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Olive View- UCLA Medical Center

Sylmar, California, United States

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John Muir Medical Center- Walnut Creek Campus

Walnut Creek, California, United States

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St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

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Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

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George Washington University Hospital

Washington D.C., District of Columbia, United States

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Morton Plant Hospital

Clearwater, Florida, United States

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Broward Health

Fort Lauderdale, Florida, United States

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UF Health Shands Hospital

Gainesville, Florida, United States

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UF Jacksonville

Jacksonville, Florida, United States

Site Status

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

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Sarasota Memorial Hospital

Sarasota, Florida, United States

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Tampa General Hospital

Tampa, Florida, United States

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St. Joseph's Hospital

Tampa, Florida, United States

Site Status

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States

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University of Chicago

Chicago, Illinois, United States

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OSF Saint Francis Medical Center

Peoria, Illinois, United States

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Memorial Medical Center

Springfield, Illinois, United States

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Iowa Methodist

Des Moines, Iowa, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

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Norton HealthCare

Louisville, Kentucky, United States

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Ochsner Medical Center - Main Campus

New Orleans, Louisiana, United States

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University Health Shreveport

Shreveport, Louisiana, United States

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University of Maryland

Baltimore, Maryland, United States

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Tufts Medical Center

Boston, Massachusetts, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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UMass Memorial Medical Center,

Worcester, Massachusetts, United States

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Henry Ford Hospital

Detroit, Michigan, United States

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McLaren Flint

Flint, Michigan, United States

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Trinity Health Saint Mary's

Grand Rapids, Michigan, United States

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Bronson Methodist Hospital

Kalamazoo, Michigan, United States

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Mayo Clinic Saint Marys Campus

Rochester, Minnesota, United States

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Saint Cloud/Centracare Health

Saint Cloud, Minnesota, United States

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University of Mississippi Medical Center

Jackson, Mississippi, United States

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Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

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Cox Medical Center

Springfield, Missouri, United States

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Barnes-Jewish Hospital

St Louis, Missouri, United States

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University of Nebraska Medical Center

Omaha, Nebraska, United States

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JFK Neuroscience Institute

Edison, New Jersey, United States

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Cooperman Barnabas Medical Center

Livingston, New Jersey, United States

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Hackensack Meridian Jersey Shore University Medical Center

Neptune City, New Jersey, United States

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University of New Mexico Hospital

Albuquerque, New Mexico, United States

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Maimonides Medical Center

Brooklyn, New York, United States

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NYU Langone Brooklyn

Brooklyn, New York, United States

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Buffalo General Medical Center

Buffalo, New York, United States

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North Shore University Hospital

Manhasset, New York, United States

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Bellevue Hospital

New York, New York, United States

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NYU Langone -Tish Hospital Medical Center

New York, New York, United States

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NYP Columbia University Medical Center

New York, New York, United States

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Strong Memorial Hospital

Rochester, New York, United States

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Staten Island University Hospital

Staten Island, New York, United States

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Suny Upstate Medical University

Syracuse, New York, United States

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Carolinas Medical Center Atrium Health

Charlotte, North Carolina, United States

Site Status

Carolinas Rehab Northeast

Concord, North Carolina, United States

Site Status

Guilford Neurologic Associates, Inc

Greensboro, North Carolina, United States

Site Status

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Christ Hospital

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

UH Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

OSU Wexner Medical Center

Columbus, Ohio, United States

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West Chester Hospital

West Chester, Ohio, United States

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St. John Health System

Tulsa, Oklahoma, United States

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Providence St. Vincent Medical Center

Portland, Oregon, United States

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St. Luke's University Hospital Bethlehem Campus

Bethlehem, Pennsylvania, United States

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Geisinger Clinic

Danville, Pennsylvania, United States

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Penn State Milton S. Hershey Center

Hershey, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Palmetto Health Richland

Columbia, South Carolina, United States

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Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

Fort Sanders Regional Medical Center

Knoxville, Tennessee, United States

Site Status

Methodist University

Memphis, Tennessee, United States

Site Status

Baylor Scott & White Institute of Rehabilitation

Dallas, Texas, United States

Site Status

Memorial Hermann Texas Medical Center

Houston, Texas, United States

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Intermountain Medical Center

Murray, Utah, United States

Site Status

University of Utah Healthcare

Salt Lake City, Utah, United States

Site Status

The University of Vermont Medical Center Main Campus

Burlington, Vermont, United States

Site Status

UVA Medical Center

Charlottesville, Virginia, United States

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Inova Fairfax

Falls Church, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Ruby Memorial Hospital

Morgantown, West Virginia, United States

Site Status

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin University Hospital

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Brown DL, Novitski K, Sickler JB, Hankla RM, Khattak F, Philpot E, Durkalski-Mauldin V, Sayyahmelli S, Patino C, Arevalo-Bermudez F, Roberts M, Sahelian A, Chervin RD. Use of a Generative Pretrained Transformer to Answer Questions and Facilitate a Large Randomized Controlled Trial. J Am Heart Assoc. 2025 Oct 21;14(20):e043333. doi: 10.1161/JAHA.125.043333. Epub 2025 Oct 21.

Reference Type DERIVED
PMID: 41120814 (View on PubMed)

Other Identifiers

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1U01NS099043-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00147316

Identifier Type: -

Identifier Source: org_study_id

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