Sleep for Stroke Management and Recovery Trial

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.

Inclusion Criteria:

1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.

Exclusion Criteria:

1. pre-event inability to perform all of own basic ADLs

2. unable to obtain informed consent from subject or legally authorized representative

3. incarcerated

4. known pregnancy

5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy

6. current use of positive airway pressure, or use within one month prior to stroke

7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible

8. severe bullous lung disease

9. history of prior spontaneous pneumothorax or current pneumothorax

10. hypotension requiring current treatment with pressors (can enroll later if this
resolves)

11. 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

12. massive epistaxis or previous history of massive epistaxis

13. cranial surgery or head trauma within the past 6 months, with known or possible CSF
leak or pneumocephalus

14. 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

15. current receipt of oxygen supplementation >4 liters per minute