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Search / Trial NCT03812653

Sleep for Stroke Management and Recovery Trial

Launched by UNIVERSITY OF MICHIGAN · Jan 18, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The Sleep for Stroke Management and Recovery Trial is a study investigating whether treating a condition called obstructive sleep apnea (OSA) with a device that helps keep the airway open (called CPAP) can help patients who have recently had an ischemic stroke. The goal is to see if starting this treatment soon after the stroke can lower the chances of having another stroke or serious heart problems and improve recovery after three months.

To participate in this trial, patients must have had a stroke within the last week and be able to respond to some basic assessments. The study is open to all adults aged 65 to 74. Participants will receive the CPAP treatment and will be monitored to see how it affects their health over the next few months. It’s important to note that some people, such as those who cannot consent or have certain medical conditions, may not be eligible to join the study.

Gender

ALL

Eligibility criteria

  • 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

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Philadelphia, Pennsylvania, United States

Boston, Massachusetts, United States

Brooklyn, New York, United States

Boston, Massachusetts, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Bronx, New York, United States

Iowa City, Iowa, United States

Saint Louis, Missouri, United States

Boston, Massachusetts, United States

Kalamazoo, Michigan, United States

Maywood, Illinois, United States

Bridgeport, Connecticut, United States

Detroit, Michigan, United States

Cincinnati, Ohio, United States

La Crosse, Wisconsin, United States

Los Angeles, California, United States

Manhasset, New York, United States

Boston, Massachusetts, United States

Sarasota, Florida, United States

Staten Island, New York, United States

Tulsa, Oklahoma, United States

Jacksonville, Florida, United States

Cleveland, Ohio, United States

Louisville, Kentucky, United States

Jackson, Mississippi, United States

Chicago, Illinois, United States

Miami, Florida, United States

Portland, Oregon, United States

Washington, District Of Columbia, United States

Clearwater, Florida, United States

Springfield, Illinois, United States

Boston, Massachusetts, United States

Omaha, Nebraska, United States

Seattle, Washington, United States

Cleveland, Ohio, United States

Hartford, Connecticut, United States

Downey, California, United States

Syracuse, New York, United States

Sacramento, California, United States

Dallas, Texas, United States

Miami, Florida, United States

Columbia, South Carolina, United States

Edison, New Jersey, United States

Detroit, Michigan, United States

Peoria, Illinois, United States

Tampa, Florida, United States

Springfield, Illinois, United States

Birmingham, Alabama, United States

Rochester, New York, United States

Cincinnati, Ohio, United States

Tampa, Florida, United States

Grand Rapids, Michigan, United States

Kansas City, Missouri, United States

Murray, Utah, United States

Minneapolis, Minnesota, United States

Springfield, Missouri, United States

Greenville, South Carolina, United States

Columbia, Missouri, United States

Richmond, Virginia, United States

Winston Salem, North Carolina, United States

Atlanta, Georgia, United States

Pittsburgh, Pennsylvania, United States

Los Angeles, California, United States

New Haven, Connecticut, United States

Buffalo, New York, United States

Houston, Texas, United States

Carmichael, California, United States

Danville, Pennsylvania, United States

Phoenix, Arizona, United States

Sylmar, California, United States

Knoxville, Tennessee, United States

New York, New York, United States

Falls Church, Virginia, United States

Flint, Michigan, United States

Miami, Florida, United States

Murray, Utah, United States

Orange, California, United States

Charlottesville, Virginia, United States

Grand Rapids, Michigan, United States

Chandler, Arizona, United States

San Diego, California, United States

Columbus, Ohio, United States

Harlingen, Texas, United States

Toledo, Ohio, United States

Chicago, Illinois, United States

Springfield, Massachusetts, United States

Portland, Oregon, United States

Albuquerque, New Mexico, United States

Seattle, Washington, United States

Salt Lake City, Utah, United States

Jacksonville, Florida, United States

New York, New York, United States

West Chester, Ohio, United States

Grand Junction, Colorado, United States

Santa Ana, California, United States

Jacksonville, Florida, United States

Shreveport, Louisiana, United States

Sioux Falls, South Dakota, United States

Phoenix, Arizona, United States

Morgantown, West Virginia, United States

Phoenix, Arizona, United States

Saint Louis, Missouri, United States

Pomona, California, United States

Tucson, Arizona, United States

Tucson, Arizona, United States

La Jolla, California, United States

Los Angeles, California, United States

Modesto, California, United States

Ontario, California, United States

San Francisco, California, United States

Walnut Creek, California, United States

Gainesville, Florida, United States

Edgewood, Kentucky, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Rochester, Minnesota, United States

Saint Cloud, Minnesota, United States

Brooklyn, New York, United States

New York, New York, United States

Charlotte, North Carolina, United States

Concord, North Carolina, United States

Greensboro, North Carolina, United States

Fargo, North Dakota, United States

Cleveland, Ohio, United States

Bethlehem, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Burlington, Vermont, United States

Madison, Wisconsin, United States

Livingston, New Jersey, United States

Neptune, New Jersey, United States

Grand Rapids, Michigan, United States

La Jolla, California, United States

Worcester, Massachusetts, United States

Redwood City, California, United States

Fort Lauderdale, Florida, United States

Des Moines, Iowa, United States

Patients applied

0 patients applied

Trial Officials

Devin Brown, MD, MS

Principal Investigator

University of Michigan

Ronald Chervin, MD, MS

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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