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SleepSMART: Sleep for Stroke Management and Recovery Trial

Supported by: National Institute of Neurological Disorders and Stroke (NINDS)

Principal Investigator at BMC: J Rafael Romero, MD

Primary Research Contact: Harshitha Shanbhogue, MBBS (617-638-7756)


SleepSMART is an 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. 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.

Enrollment Criteria

Inclusion Criteria:

  1. Age ≥18
  2. TIA with ABCD2 ≥4 or ischemic stroke within the prior 14 days.

Exclusion Criteria:

  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

Status: Actively enrolling patients