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Sleep SMART: Sleep for Stroke Management And Recovery Trial

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

Investigator-initiated, phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.

Intervention: Autoadjusting continuous positive airway pressure (aPAP) delivered with the ResMed AirSense 10 or 11 AutoSet.

Control: usual care.

Participant Duration: 6 months.

The primary goals of this study are to determine whether treatment
of OSA with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (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.


Details

Protocol number CED000000869

Eligibility

In order to be eligible to participate in this study, an individual must meet all of the following

criteria:
1. Age ≥18
2. Ischemic stroke (as defined in the outcome section84), within the prior 7 days.
3. NIHSS ≥1

An individual who meets any of the following criteria is excluded from participation in this study:
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

Lead researchers

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