Sleep for Stroke Management and Recovery Trial (Sleep SMART)

Clinical Trial Title

Sleep for Stroke Management and Recovery Trial (Sleep SMART)

National Clinical Trial Number:

NCT03812653

Contact Information

Clinical Trial Protocol Description:

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.

Clinical Trial Eligibility Criteria:

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.

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.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Laurel Cherian, MD, MS

Contact Information

Henna McCoy

Clinical Trial Location

Rush University Medical Center

Location

Rush University Medical Center

1620 W Harrison St
Chicago, IL 60612

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