Sleep for Stroke Management and Recovery Trial
Purpose
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.
Conditions
- Ischemic Stroke
- Sleep Apnea
- Sleep Apnea, Obstructive
- Stroke
- CPAP
- Telemedicine
- Home Sleep Apnea Test
- Randomized Clinical Trial
- Multicenter Trial
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Arm: CPAP with Usual Care. |
6 months of CPAP plus usual medical therapy. |
|
|
No Intervention Control Arm: Usual Care. |
6 months of usual medical therapy alone. |
|
Recruiting Locations
Chandler, Arizona 85224
Phoenix, Arizona 85006
Phoenix, Arizona 85013
Tucson, Arizona 85719
La Jolla, California 92037
Los Angeles, California 90048
Los Angeles, California 90095
Los Angeles, California 94612
Modesto, California 95355
Sacramento, California 95817
San Diego, California 92103
San Francisco, California 94143
Santa Ana, California 92705
Grand Junction, Colorado 81501
New Haven, Connecticut 06510
Washington, District of Columbia 20037
Jacksonville, Florida 32216
Sarasota, Florida 34239
Chicago, Illinois 60612
Chicago, Illinois 60637
Iowa City, Iowa 52242
Louisville, Kentucky 40218
New Orleans, Louisiana 70121
Shreveport, Louisiana 71103
Baltimore, Maryland 21201
Boston, Massachusetts 02114
Boston, Massachusetts 02215
Grand Rapids, Michigan 49503
Rochester, Minnesota 55905
Saint Cloud, Minnesota 56303
Jackson, Mississippi 39216
Kansas City, Missouri 64111
Springfield, Missouri 65807
Albuquerque, New Mexico 87106
Buffalo, New York 14203
Manhasset, New York 11030
New York, New York 10016
New York, New York 10032
Rochester, New York 14642
Staten Island, New York 10305
Charlotte, North Carolina 28203
Concord, North Carolina 28025
Greensboro, North Carolina 27401
Winston-Salem, North Carolina 27157
Cincinnati, Ohio 45219
Cleveland, Ohio 11100
Portland, Oregon 97225
Bethlehem, Pennsylvania 18015
Hershey, Pennsylvania 17033
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19122
Columbia, South Carolina 29203
Greenville, South Carolina 29605
Sioux Falls, South Dakota 57108
Dallas, Texas 75246
Houston, Texas 77030
Salt Lake City, Utah 84132
Burlington, Vermont 05401
Richmond, Virginia 23219
Morgantown, West Virginia 26506
Madison, Wisconsin 53715
More Details
- NCT ID
- NCT03812653
- Status
- Recruiting
- Sponsor
- University of Michigan
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.