Sleep for Stroke Management and Recovery Trial (Sleep SMART)
U01NS099043
Overview:
Sleep SMART is a phase 3 multi-site, parallel-group superiority trial with a prospective, randomized, open-label, blinded-endpoint (PROBE) design. The primary goals of this study are to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure started shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality during 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. The 5-year study includes two trials: a prevention study with an embedded recovery trial. Sleep SMART aims to randomize 3,062 subjects at 110 sites within StrokeNet , an NINDS-funded clinical trials network.
Principal Investigators:
Devin Brown, MD, MS, University of Michigan
Ronald Chervin, MD, MS, University of Michigan
Co-investigators and/or event adjudicators:
Deborah Levine, MD, MPH, University of Michigan
Lewis Morgenstern, MD, University of Michigan
Darin Zahuranec, MD, MS, University of Michigan
StrokeNet National Data Management Center (NDMC) Project PI:
Valerie Durkalski, PhD, Medical University of South Carolina
StrokeNet National Coordinating Center (NCC) PI:
Joseph Broderick, MD, University of Cincinnati
StrokeNet NDMC PI:
Yuko Palesch, PhD, Medical University of South Carolina
Telemedicine investigator:
Jeffrey Durmer, MD, PhD, FusionHealth
NINDS:
Claudia Moy, PhD, Project Scientist
Joanna Vivalda, RN, MBA, CCRA, Program Official
Scott Janis, PhD, StrokeNet Project Scientist
Consultants:
Craig Anderson, MBBS, PhD, FRACP, The George Institute, University of Sydney, Australia
Dawn M. Bravata, MD, University of Indiana
H. Klar Yaggi, MD, MPH, Yale University
Independent Medical Safety Monitors:
Kingman Strohl,MD, Case Western Reserve University
Anna May, MD, MS,Case Western Reserve University
For more information:
StrokeNet Sleep SMART website: https://www.nihstrokenet.org/sleep-smart-trial/home
ClinicalTrails.gov Identifier: NCT03812653
