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Ischemic StrokeSleep SMARTNCT03812653

Sleep for Stroke Management and Recovery Trial

A study testing CPAP in people with Ischemic Stroke and Sleep Apnea, run by University of Michigan at 116 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,062 participants
Where
116 sitesUnited States
Study dates
9 May 2019to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • current contact, droplet, respiratory/airborne precautions

Trial locations and contacts

116 sites in 1 country.

116 sites in 1 country

United States116 sites

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • University of Maryland

    Baltimore, Maryland, 21201

  • St. Luke's University Hospital Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • University of Alabama Hospital

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • NYU Langone Brooklyn

    Brooklyn, New York, 11220

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • The University of Vermont Medical Center Main Campus

    Burlington, Vermont, 05401

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • Carolinas Medical Center Atrium Health

    Charlotte, North Carolina, 28203

  • UVA Medical Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • UH Cleveland Medical Center

    Cleveland, Ohio, 11100

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Palmetto Health Richland

    Columbia, South Carolina, 29203

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

  • Carolinas Rehab Northeast

    Concord, North Carolina, 28025

  • Baylor Scott & White Institute of Rehabilitation

    Dallas, Texas, 75246

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Iowa Methodist

    Des Moines, Iowa, 50309

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

  • JFK Neuroscience Institute

    Edison, New Jersey, 08820

  • Inova Fairfax

    Falls Church, Virginia, 22042

  • McLaren Flint

    Flint, Michigan, 48532

  • Broward Health

    Fort Lauderdale, Florida, 33305

  • UF Health Shands Hospital

    Gainesville, Florida, 32611

  • St. Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81501

  • Trinity Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Guilford Neurologic Associates, Inc

    Greensboro, North Carolina, 27401

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Milton S. Hershey Center

    Hershey, Pennsylvania, 17033

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • UF Jacksonville

    Jacksonville, Florida, 32209

  • Brooks Rehabilitation Hospital

    Jacksonville, Florida, 32216

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49008

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Fort Sanders Regional Medical Center

    Knoxville, Tennessee, 37916

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • Scripps Memorial

    La Jolla, California, 92037

  • UCSD Health La Jolla

    La Jolla, California, 92103

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • Kaiser Permanente Los Angeles

    Los Angeles, California, 94612

  • Norton HealthCare

    Louisville, Kentucky, 40218

  • University of Wisconsin University Hospital

    Madison, Wisconsin, 53715

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Methodist University

    Memphis, Tennessee, 38105

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Doctors Medical Center of Modesto

    Modesto, California, 95355

  • Ruby Memorial Hospital

    Morgantown, West Virginia, 26506

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Hackensack Meridian Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Ochsner Medical Center - Main Campus

    New Orleans, Louisiana, 70121

  • Bellevue Hospital

    New York, New York, 10016

  • NYU Langone -Tish Hospital Medical Center

    New York, New York, 10016

  • NYP Columbia University Medical Center

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UCLA Kaiser Fontana

    Ontario, California, 91761

  • UC Irvine

    Orange, California, 92868

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61603

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19122

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

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

    Phoenix, Arizona, 85013

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Casa Colina

    Pomona, California, 91767

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Redwood

    Redwood City, California, 94063

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Mayo Clinic Saint Marys Campus

    Rochester, Minnesota, 55905

  • Strong Memorial Hospital

    Rochester, New York, 14642

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Saint Cloud/Centracare Health

    Saint Cloud, Minnesota, 56303

  • University of Utah Healthcare

    Salt Lake City, Utah, 84132

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California, 92103

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143

  • Orange County Global Medical Center

    Santa Ana, California, 92705

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Harborview Medical Center

    Seattle, Washington, 98195

  • University Health Shreveport

    Shreveport, Louisiana, 71103

  • Avera Research Institute

    Sioux Falls, South Dakota, 57108

  • Memorial Medical Center

    Springfield, Illinois, 62702

  • Cox Medical Center

    Springfield, Missouri, 65807

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Olive View- UCLA Medical Center

    Sylmar, California, 91342

  • Suny Upstate Medical University

    Syracuse, New York, 13210

  • Tampa General Hospital

    Tampa, Florida, 33606

  • St. Joseph's Hospital

    Tampa, Florida, 33607

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • TMC Healthcare

    Tucson, Arizona, 85712

  • Banner- University Medical Center Tucson

    Tucson, Arizona, 85719

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • John Muir Medical Center- Walnut Creek Campus

    Walnut Creek, California, 94598

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • West Chester Hospital

    West Chester, Ohio, 45069

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center,

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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.

Read the 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.

Being tested
CPAP
Medical subject headings
Ischemic Stroke, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAPDevice

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

Study groups in NCT03812653
Study groupRoleWhat they receive
Intervention Arm: CPAP with Usual Care.Experimental6 months of CPAP plus usual medical therapy.
Receives: Device: CPAP
Control Arm: Usual Care.No intervention6 months of usual medical therapy alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months post randomization

  2. 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).

    Measured: 3 months post randomization

Secondary outcomes (3)

  1. NIH Stroke Score (NIHSS)

    Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.

    Measured: 3 months post randomization

  2. 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.

    Measured: 3 months post randomization

  3. 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.

    Measured: 3 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start9 May 2019
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,062 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812653
Sponsor's protocol ID
HUM00147316
Other IDs
1U01NS099043-01A1
Acronym
Sleep SMART
Status last verified
Jan 2026
First submitted
18 Jan 2019
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • Brown DL, Durmer JS, Aloia M, Hankla RM, Novitski K, Sickler JB, Considine S, Delacroix E, Ong JC, Baran AS, Anderson CS, Bravata DM, Yaggi HK, Durkalski-Mauldin V, Chervin RD. A multilevel CPAP support strategy implemented within a large stroke clinical trial (sleep SMART). Front Sleep. 2026 May 25;5:1832143. doi: 10.3389/frsle.2026.1832143. eCollection 2026.

    PubMed 42266869

  • 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.

    PubMed 41120814

Questions about this trial

What is this clinical trial studying?

A study testing CPAP in people with Ischemic Stroke and Sleep Apnea, run by University of Michigan at 116 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality (time frame: 6 months post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03812653, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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