Sleep for Stroke Management and Recovery Trial (Sleep SMART)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Sleep Apnea, Obstructive; Ischemic Stroke; Sleep Apnea; Telemedicine; Randomized Clinical Trial; CPAP; Home Sleep Apnea Test; Multicenter Trial
• Intervention / Treatment: Device: CPAP

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.

• Study Type: Interventional
• Enrollment (Estimated): 3062
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Hospital
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Chandler Regional Medical Center
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix
    • Phoenix, Arizona, United States, 85013
      • Dignity Health - St. Joseph's Hospital and Medical Center
    • Tucson, Arizona, United States, 85712
      • TMC HealthCare
    • Tucson, Arizona, United States, 85719
      • Banner- University Medical Center Tucson
  • California
    • Carmichael, California, United States, 95608
      • Mercy San Juan Medical Center
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center
    • La Jolla, California, United States, 92037
      • Scripps Memorial
    • La Jolla, California, United States, 92103
      • UCSD Health La Jolla
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 94612
      • Kaiser Permanente Los Angeles
    • Modesto, California, United States, 95355
      • Doctors Medical Center of Modesto
    • Ontario, California, United States, 91761
      • UCLA Kaiser Fontana
    • Orange, California, United States, 92868
      • UC Irvine
    • Pomona, California, United States, 91767
      • Casa Colina
    • Redwood City, California, United States, 94063
      • Kaiser Redwood
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • San Diego, California, United States, 92103
      • UCSD Medical Center - Hillcrest Hospital
    • San Francisco, California, United States, 94143
      • UCSF Helen Diller Medical Center at Parnassus Heights
    • Santa Ana, California, United States, 92705
      • Orange County Global Medical Center
    • Sylmar, California, United States, 91342
      • Olive View- UCLA Medical Center
    • Walnut Creek, California, United States, 94598
      • John Muir Medical Center- Walnut Creek Campus
  • Colorado
    • Grand Junction, Colorado, United States, 81501
      • St. Mary's Hospital and Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Fort Lauderdale, Florida, United States, 33305
      • Broward Health
    • Gainesville, Florida, United States, 32611
      • UF Health Shands Hospital
    • Jacksonville, Florida, United States, 32216
      • Brooks Rehabilitation Hospital
    • Jacksonville, Florida, United States, 32209
      • UF Jacksonville
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33607
      • St. Joseph's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60612
      • University of Illinois Hospital and Health Sciences System
    • Peoria, Illinois, United States, 61603
      • OSF Saint Francis Medical Center
    • Springfield, Illinois, United States, 62702
      • Memorial Medical Center
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40218
      • Norton Healthcare
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center - Main Campus
    • Shreveport, Louisiana, United States, 71103
      • University Health Shreveport
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center,
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Flint, Michigan, United States, 48532
      • McLaren Flint
    • Grand Rapids, Michigan, United States, 49503
      • Trinity Health Saint Mary's
    • Kalamazoo, Michigan, United States, 49008
      • Bronson Methodist Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Saint Marys Campus
    • Saint Cloud, Minnesota, United States, 56303
      • Saint Cloud/Centracare Health
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Springfield, Missouri, United States, 65807
      • Cox Medical Center
    • St Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • JFK Neuroscience Institute
    • Livingston, New Jersey, United States, 07039
      • Cooperman Barnabas Medical Center
    • Neptune City, New Jersey, United States, 07753
      • Hackensack Meridian Jersey Shore University Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Hospital
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Brooklyn, New York, United States, 11220
      • NYU Langone Brooklyn
    • Buffalo, New York, United States, 14203
      • Buffalo General Medical Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10016
      • Bellevue Hospital
    • New York, New York, United States, 10032
      • NYP Columbia University Medical Center
    • New York, New York, United States, 10016
      • NYU Langone -Tish Hospital Medical Center
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center Atrium Health
    • Concord, North Carolina, United States, 28025
      • Carolinas Rehab Northeast
    • Greensboro, North Carolina, United States, 27401
      • Guilford Neurologic Associates, Inc
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 11100
      • UH Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • OSU Wexner Medical Center
    • West Chester, Ohio, United States, 45069
      • West Chester Hospital
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital Bethlehem Campus
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health Richland
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Research Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Regional Medical Center
    • Memphis, Tennessee, United States, 38105
      • Methodist University
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Institute of Rehabilitation
    • Houston, Texas, United States, 77030
      • Memorial Hermann Texas Medical Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Healthcare
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center Main Campus
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • UVA Medical Center
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98195
      • Harborview Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Ruby Memorial Hospital
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundation
    • Madison, Wisconsin, United States, 53715
      • University of Wisconsin University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm: CPAP with Usual Care.; 6 months of CPAP plus usual medical therapy.	Device: CPAP; Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
No Intervention: Control Arm: Usual Care.; 6 months of usual medical therapy alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH Stroke Score (NIHSS)	Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.	3 months post randomization
Short Montreal Cognitive Assessment (MoCA) Score	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.	3 months post randomization
Quality of Life outcome	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.	3 months post randomization

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Medical University of South Carolina; National Institute of Neurological Disorders and Stroke (NINDS); University of Cincinnati; FusionHealth LLC
• Investigators: Principal Investigator: Devin Brown, MD, MS, University of Michigan; Principal Investigator: Ronald Chervin, MD, MS, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Ischemic Stroke; Stroke; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: HUM00147316; 1U01NS099043-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No