Status:
ACTIVE_NOT_RECRUITING
Sleep for Stroke Management and Recovery Trial
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
FusionHealth LLC
Conditions:
Ischemic Stroke
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, ac...
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 ...
Eligibility Criteria
Inclusion
- Current Inclusion Criteria, as of 6/28/2024:
- Ischemic stroke within the prior 7 days.
- 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):
- 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
- 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
Exclusion
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
3062 Patients enrolled
Trial Details
Trial ID
NCT03812653
Start Date
May 9 2019
End Date
November 1 2026
Last Update
January 7 2026
Active Locations (116)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama Hospital
Birmingham, Alabama, United States, 35294
2
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
3
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
4
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013