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Clinical Trials in Mexico / NCT03812653
Active, not recruiting Not applicable

Sleep for Stroke Management and Recovery Trial

NCT03812653 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2019-05-09
Last updated
2026-02-02

Condition(s) studied

Ischemic StrokeSleep ApneaSleep Apnea, ObstructiveStrokeCPAPTelemedicineHome Sleep Apnea TestRandomized Clinical TrialMulticenter Trial

Investigational drug(s) / intervention(s)

CPAP

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

Study 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 in patients who experienced an ischemic stroke.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (116)

FacilityCityRegionStatus
University of Alabama Hospital Birmingham Alabama
Chandler Regional Medical Center Chandler Arizona
Banner University Medical Center Phoenix Phoenix Arizona
Dignity Health - St. Joseph's Hospital and Medical Center Phoenix Arizona
TMC Healthcare Tucson Arizona
Banner- University Medical Center Tucson Tucson Arizona
Mercy San Juan Medical Center Carmichael California
Rancho Los Amigos National Rehabilitation Center Downey California
Scripps Memorial La Jolla California
UCSD Health La Jolla La Jolla California
Cedars-Sinai Medical Center Los Angeles California
Ronald Reagan UCLA Medical Center Los Angeles California
Kaiser Permanente Los Angeles Los Angeles California
Doctors Medical Center of Modesto Modesto California
UCLA Kaiser Fontana Ontario California
UC Irvine Orange California
Casa Colina Pomona California
Kaiser Redwood Redwood City California
UC Davis Medical Center Sacramento California
UCSD Medical Center - Hillcrest Hospital San Diego California
UCSF Helen Diller Medical Center at Parnassus Heights San Francisco California
Orange County Global Medical Center Santa Ana California
Olive View- UCLA Medical Center Sylmar California
John Muir Medical Center- Walnut Creek Campus Walnut Creek California
St. Mary's Hospital and Medical Center Grand Junction Colorado
Hartford Hospital Hartford Connecticut
Yale-New Haven Hospital New Haven Connecticut
George Washington University Hospital Washington D.C. District of Columbia
Morton Plant Hospital Clearwater Florida
Broward Health Fort Lauderdale Florida
UF Health Shands Hospital Gainesville Florida
UF Jacksonville Jacksonville Florida
Brooks Rehabilitation Hospital Jacksonville Florida
Jackson Memorial Hospital Miami Florida
Baptist Hospital of Miami Miami Florida
Sarasota Memorial Hospital Sarasota Florida
Tampa General Hospital Tampa Florida
St. Joseph's Hospital Tampa Florida
Grady Memorial Hospital Atlanta Georgia
Rush University Medical Center Chicago Illinois

+ 76 more sites — see the full list on the official registry below.

More University of Michigan trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03812653 on ClinicalTrials.gov ↗ ← All trials in Mexico