Sleep for Stroke Management and Recovery Trial
Sleep SMART
2 other identifiers
interventional
3,062
1 country
116
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2019
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedStudy Start
First participant enrolled
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
February 2, 2026
January 1, 2026
7.5 years
January 18, 2019
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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).
3 months post randomization
Secondary Outcomes (3)
NIH Stroke Score (NIHSS)
3 months post randomization
Short Montreal Cognitive Assessment (MoCA) Score
3 months post randomization
Quality of Life outcome
3 months post randomization
Study Arms (2)
Intervention Arm: CPAP with Usual Care.
EXPERIMENTAL6 months of CPAP plus usual medical therapy.
Control Arm: Usual Care.
NO INTERVENTION6 months of usual medical therapy alone.
Interventions
Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
Eligibility Criteria
You may qualify if:
- Ischemic stroke within the prior 7 days.
- NIH Stroke Scale Score ≥1 at the time of enrollment
- \. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.
You may not qualify if:
- pre-event inability to perform all of own basic ADLs
- unable to obtain informed consent from subject or legally authorized representative
- incarcerated
- known pregnancy
- current mechanical ventilation (can enroll later if this resolves) or tracheostomy
- current use of positive airway pressure, or use within one month prior to stroke
- anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
- severe bullous lung disease
- history of prior spontaneous pneumothorax or current pneumothorax
- hypotension requiring current treatment with pressors (can enroll later if this resolves)
- 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
- massive epistaxis or previous history of massive epistaxis
- cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
- 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
- current receipt of oxygen supplementation \>4 liters per minute
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- FusionHealth LLCcollaborator
- Medical University of South Carolinacollaborator
- University of Cincinnaticollaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (116)
University of Alabama Hospital
Birmingham, Alabama, 35294, United States
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
TMC Healthcare
Tucson, Arizona, 85712, United States
Banner- University Medical Center Tucson
Tucson, Arizona, 85719, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Scripps Memorial
La Jolla, California, 92037, United States
UCSD Health La Jolla
La Jolla, California, 92103, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Kaiser Permanente Los Angeles
Los Angeles, California, 94612, United States
Doctors Medical Center of Modesto
Modesto, California, 95355, United States
UCLA Kaiser Fontana
Ontario, California, 91761, United States
UC Irvine
Orange, California, 92868, United States
Casa Colina
Pomona, California, 91767, United States
Kaiser Redwood
Redwood City, California, 94063, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, 92103, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143, United States
Orange County Global Medical Center
Santa Ana, California, 92705, United States
Olive View- UCLA Medical Center
Sylmar, California, 91342, United States
John Muir Medical Center- Walnut Creek Campus
Walnut Creek, California, 94598, United States
St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81501, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Broward Health
Fort Lauderdale, Florida, 33305, United States
UF Health Shands Hospital
Gainesville, Florida, 32611, United States
UF Jacksonville
Jacksonville, Florida, 32209, United States
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
St. Joseph's Hospital
Tampa, Florida, 33607, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61603, United States
Memorial Medical Center
Springfield, Illinois, 62702, United States
Iowa Methodist
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Norton HealthCare
Louisville, Kentucky, 40218, United States
Ochsner Medical Center - Main Campus
New Orleans, Louisiana, 70121, United States
University Health Shreveport
Shreveport, Louisiana, 71103, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center,
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
McLaren Flint
Flint, Michigan, 48532, United States
Trinity Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49008, United States
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, 55905, United States
Saint Cloud/Centracare Health
Saint Cloud, Minnesota, 56303, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Cox Medical Center
Springfield, Missouri, 65807, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
JFK Neuroscience Institute
Edison, New Jersey, 08820, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Hackensack Meridian Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
NYU Langone Brooklyn
Brooklyn, New York, 11220, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Bellevue Hospital
New York, New York, 10016, United States
NYU Langone -Tish Hospital Medical Center
New York, New York, 10016, United States
NYP Columbia University Medical Center
New York, New York, 10032, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
Suny Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center Atrium Health
Charlotte, North Carolina, 28203, United States
Carolinas Rehab Northeast
Concord, North Carolina, 28025, United States
Guilford Neurologic Associates, Inc
Greensboro, North Carolina, 27401, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
UH Cleveland Medical Center
Cleveland, Ohio, 11100, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OSU Wexner Medical Center
Columbus, Ohio, 43210, United States
West Chester Hospital
West Chester, Ohio, 45069, United States
St. John Health System
Tulsa, Oklahoma, 74104, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
St. Luke's University Hospital Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Penn State Milton S. Hershey Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19122, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916, United States
Methodist University
Memphis, Tennessee, 38105, United States
Baylor Scott & White Institute of Rehabilitation
Dallas, Texas, 75246, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah Healthcare
Salt Lake City, Utah, 84132, United States
The University of Vermont Medical Center Main Campus
Burlington, Vermont, 05401, United States
UVA Medical Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98195, United States
Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601, United States
University of Wisconsin University Hospital
Madison, Wisconsin, 53715, United States
Related Publications (1)
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.
PMID: 41120814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Devin Brown, MD, MS
University of Michigan
- PRINCIPAL INVESTIGATOR
Ronald Chervin, MD, MS
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Neurology
Study Record Dates
First Submitted
January 18, 2019
First Posted
January 23, 2019
Study Start
May 9, 2019
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
We will comply with the NIH Data Sharing Policy, Policy on the Dissemination of NIH-Funded Clinical Trial Information, the Clinical Trials Registration and Results Information Submission rule, and StrokeNet SOP on Network Data Sharing Policy. NDMC statisticians will generate data files from each data table and in compliance with HIPAA regulations each table will be de-identified. A minimum number of derived variables necessary to reproduce the primary analysis will be created. Within a year from acceptance of the primary manuscript or no later than two years from database lock, the public-use data sets will be submitted to the NINDS data repository along with final version of the study protocol, data dictionary and a user guide. Data along with signals from sleep apnea recordings will be submitted to the NHLBI National Sleep Research Resource.