Trials / Active Not Recruiting
Active Not RecruitingNCT03812653
Sleep for Stroke Management and Recovery Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3,062 (estimated)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Ischemic Stroke
- Sleep Apnea
- Sleep Apnea, Obstructive
- Stroke
- CPAP
- Telemedicine
- Home Sleep Apnea Test
- Randomized Clinical Trial
- Multicenter Trial
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CPAP | Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device. |
Timeline
- Start date
- 2019-05-09
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2019-01-23
- Last updated
- 2026-02-02
Locations
116 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03812653. Inclusion in this directory is not an endorsement.