Summary

for people ages 18 years and up (full criteria)
at Fresno, California and other locations
study started
estimated completion
Stuart Glassner, MD Wade Smith, MD, PhD

Description

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 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

Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Keywords

Ischemic Stroke Sleep Apnea Sleep Apnea, Obstructive TIA Stroke CPAP Telemedicine Home Sleep Apnea Test Randomized Clinical Trial Multicenter Trial Apnea Sleep Apnea Syndromes

Eligibility

You can join if…

Open to people ages 18 years and up

  1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.

You CAN'T join if...

  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

Locations

  • Community Regional Medical Center of Fresno not yet accepting patients
    Fresno California 93701 United States
  • UCSF Helen Diller Medical Center at Parnassus Heights not yet accepting patients
    San Francisco California 94143 United States
  • Kaiser Permanente Los Angeles not yet accepting patients
    Los Angeles California 94612 United States

Lead Scientists

  • Stuart Glassner, MD
    Stuart J. Glassner, D.O., specializes in the treatment of patients with acute life-threating neurologic conditions including traumatic brain injury, subarachnoid hemorrhage, status epilepticus, hemorrhagic, and ischemic strokes. Dr. Glassner, was resident selection for excellence in Neuro Education. In his free time, Dr. Glassner enjoys writing, improv, comedy, and exercise.
  • Wade Smith, MD, PhD
    Dr. Smith is a neurologist with training in Neurocritical Care and Vascular Neurology. He cares for patients with acute stroke and subarachnoid hemorrhage among all neurovascular conditions. His research interests are in developing methods to rapidly triage stroke patients to appropriate immediate care using biometrics, endovascular stroke therapy and cerebral concussion.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT03812653
Study Type
Interventional
Last Updated