Active — Not RecruitingNot Applicable

Sleep for Stroke Management and Recovery Trial

United States3,062 participantsStarted 2019-05-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ischemic stroke within the prior 7 days.
✓. NIH Stroke Scale Score ≥1 at the time of enrollment

Exclusion criteria

✕. 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

What they're measuring

Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality

Timeframe: 6 months post randomization

Modified Rankin Scale Score

Timeframe: 3 months post randomization

Trial details

NCT IDNCT03812653

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Ischemic Stroke trials