Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  16. current contact, droplet, respiratory/airborne precautions

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
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
Prevention
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention Arm: CPAP with Usual Care.
6 months of CPAP plus usual medical therapy.
  • Device: CPAP
    Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
No Intervention
Control Arm: Usual Care.
6 months of usual medical therapy alone.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Khadean Moncrieffe
kmoncrie@montefiore.org

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Kayla Novitski, MPH, CCRP
734-615-2006
kcgossel@med.umich.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.