Sleep for Stroke Management and Recovery Trial
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.
- Ischemic Stroke
- Sleep Apnea
- Sleep Apnea, Obstructive
- Home Sleep Apnea Test
- Randomized Clinical Trial
- Multicenter Trial
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.
- pre-event inability to perform all of own basic ADLs
- unable to obtain informed consent from subject or legally authorized representative
- 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
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
- Primary Purpose
- 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.
Intervention Arm: CPAP with Usual Care.
|6 months of CPAP plus usual medical therapy.||
Control Arm: Usual Care.
|6 months of usual medical therapy alone.||
- University of Michigan
Study ContactKayla Novitski, MPH, CCRP
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.