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(352) 733-0111

Sleep SMART

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

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.

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.

Details

Full study title Sleep for Stroke Management And Recovery Trial
Protocol number OCR22402
ClinicalTrials.gov ID NCT03812653
Phase N/A

Eligibility

Current Inclusion Criteria, as of 6/28/2024:

  1. Ischemic stroke within the prior 7 days.

  2. 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):

  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)

  1. 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

  1. massive epistaxis or previous history of massive epistaxis

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

leak or pneumocephalus

  1. 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

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

  2. current contact, droplet, respiratory/airborne precautions

Lead researcher

  • Anna Y Khanna, MD
    Vascular Neurologist (Brain Blood Vessel Specialist)
    Anna Y Khanna

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.