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 Sex
- 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
Birmingham 4049979, Alabama 4829764 35294
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85013
Tucson 5318313, Arizona 5551752 85719
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92103
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90095
Los Angeles 5368361, California 5332921 94612
Modesto 5373900, California 5332921 95355
Ontario 5379439, California 5332921 91761
Pomona 5384170, California 5332921 91767
Redwood City 5386834, California 5332921 94063
Sacramento 5389489, California 5332921 95817
San Diego 5391811, California 5332921 92103
San Francisco 5391959, California 5332921 94143
Santa Ana 5392900, California 5332921 92705
Grand Junction 5423573, Colorado 5417618 81501
Hartford 4835797, Connecticut 4831725 06102
New Haven 4839366, Connecticut 4831725 06510
Clearwater 4151316, Florida 4155751 33756
Jacksonville 4160021, Florida 4155751 32209
Jacksonville 4160021, Florida 4155751 32216
Miami 4164138, Florida 4155751 33136
Sarasota 4172131, Florida 4155751 34239
Tampa 4174757, Florida 4155751 33607
Atlanta 4180439, Georgia 4197000 30303
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60637
Springfield 4250542, Illinois 4896861 62702
Iowa City 4862034, Iowa 4862182 52242
Louisville 4299276, Kentucky 6254925 40218
Shreveport 4341513, Louisiana 4331987 71103
Baltimore 4347778, Maryland 4361885 21201
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02215
Worcester 4956184, Massachusetts 6254926 01655
Grand Rapids 4994358, Michigan 5001836 49503
Kalamazoo 4997787, Michigan 5001836 49008
Rochester 5043473, Minnesota 5037779 55905
Saint Cloud 5044407, Minnesota 5037779 56303
Jackson 4431410, Mississippi 4436296 39216
Kansas City 4393217, Missouri 4398678 64111
Springfield 4409896, Missouri 4398678 65807
St Louis 4407066, Missouri 4398678 63110
Edison 5097529, New Jersey 5101760 08820
Livingston 5100572, New Jersey 5101760 07039
Neptune City 5101687, New Jersey 5101760 07753
Albuquerque 5454711, New Mexico 5481136 87106
Brooklyn 5110302, New York 5128638 11219
Brooklyn 5110302, New York 5128638 11220
Buffalo 5110629, New York 5128638 14203
Manhasset 5125766, New York 5128638 11030
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10032
Syracuse 5140405, New York 5128638 13210
The Bronx 5110266, New York 5128638 10467
Charlotte 4460243, North Carolina 4482348 28203
Concord 4461574, North Carolina 4482348 28025
Greensboro 4469146, North Carolina 4482348 27401
Winston-Salem 4499612, North Carolina 4482348 27157
Cincinnati 4508722, Ohio 5165418 45219
Cincinnati 4508722, Ohio 5165418 45219
Cleveland 5150529, Ohio 5165418 11100
Columbus 4509177, Ohio 5165418 43210
West Chester 4520522, Ohio 5165418 45069
Tulsa 4553433, Oklahoma 4544379 74104
Portland 5746545, Oregon 5744337 97225
Hershey 5193342, Pennsylvania 6254927 17033
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19122
Pittsburgh 5206379, Pennsylvania 6254927 15213
Columbia 4575352, South Carolina 4597040 29203
Greenville 4580543, South Carolina 4597040 29605
Sioux Falls 5231851, South Dakota 5769223 57108
Knoxville 4634946, Tennessee 4662168 37916
Memphis 4641239, Tennessee 4662168 38105
Houston 4699066, Texas 4736286 77030
Murray 5778755, Utah 5549030 84107
Salt Lake City 5780993, Utah 5549030 84132
Burlington 5234372, Vermont 5242283 05401
Charlottesville 4752031, Virginia 6254928 22908
Richmond 4781708, Virginia 6254928 23219
Seattle 5809844, Washington 5815135 98195
Morgantown 4815352, West Virginia 4826850 26506
Madison 5261457, Wisconsin 5279468 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.