Sleep for Stroke Management and Recovery Trial

  • STATUS
    Recruiting
  • End date
    Nov 19, 2023
  • participants needed
    3062
  • sponsor
    University of Michigan
Updated on 19 April 2021
Investigator
Kayla Novitski, MPH, CCRP
Primary Contact
Carolinas Rehab Northeast (10.0 mi away) Contact
+137 other location
continuous positive airway pressure
stroke
acute coronary syndrome
ischemic stroke
apnea
acute stroke
obstructive sleep apnea
recurrent strokes

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.

Description

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.

Details
Condition Continuous Positive Airway Pressure, Cerebrovascular accident, Transient Ischemic Attack, Multicenter Trials, Telemedicine, randomized clinical trial, Multicenter Study, Sleep apnea, Obstructive sleep apnea, Ischemic Stroke, Continuous Positive Airway Pressure (CPAP), Sleep Apnea Syndromes, Stroke, Home Sleep Apnea Test, cpap, ventilation, cpap, transient ischemic attacks, cerebrovascular accidents, strokes, cerebral
Treatment CPAP
Clinical Study IdentifierNCT03812653
SponsorUniversity of Michigan
Last Modified on19 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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
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