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Completed
NCT03812653
Sleep for Stroke Management and Recovery Trial
Conditions: Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1892
Sponsor: University of Michigan
Location: University of Alabama Hospital Birmingham Alabama
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 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
Source: ClinicalTrials.gov (NCT03812653). StuddyBuddy aggregates publicly available trial information.