Sleep for Stroke Management and Recovery Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- CPAP
- Home Sleep Apnea Test
- Ischemic Stroke
- Multicenter Trial
- Randomized Clinical Trial
- Sleep Apnea
- Sleep Apnea - Obstructive
- Stroke
- Telemedicine
- TIA
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.Masking: Single (Outcomes Assessor)Masking Description: Eligible participants will be allocated in a 1:1 fashion to CPAP or no CPAP using a randomization method to protect subject treatment allocation and prevent potential selection biases.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03812653
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- FusionHealth LLC
- Medical University of South Carolina
- University of Cincinnati
- Investigators
- Principal Investigator: Devin Brown, MD, MS University of Michigan Principal Investigator: Ronald Chervin, MD, MS University of Michigan
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