Sleep for Stroke Management and Recovery Trial
Overview
- Phase
- Not Applicable
- Intervention
- CPAP
- Conditions
- Ischemic Stroke
- Sponsor
- University of Michigan
- Enrollment
- 3062
- Locations
- 171
- Primary Endpoint
- Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief 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 (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.
Detailed 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.
Investigators
Devin L. Brown, MD
Professor of Neurology
University of Michigan
Eligibility Criteria
Inclusion 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
- •Previous Inclusion Criteria, prior to 6/28/2024:
- •1\. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.
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
Arms & Interventions
Intervention Arm: CPAP with Usual Care.
6 months of CPAP plus usual medical therapy.
Intervention: CPAP
Control Arm: Usual Care.
6 months of usual medical therapy alone.
Outcomes
Primary Outcomes
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
Time Frame: 6 months post randomization
The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality
Modified Rankin Scale Score
Time Frame: 3 months post randomization
Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).
Secondary Outcomes
- Short Montreal Cognitive Assessment (MoCA) Score(3 months post randomization)
- NIH Stroke Score (NIHSS)(3 months post randomization)
- Quality of Life outcome(3 months post randomization)