Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(352) 733-0111

Sleep SMART

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study
Facebook
Twitter
LinkedIn

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 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.

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

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)

  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

Here are some general steps to consider when participating in a research study:

  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

    Anna Yuzefovich Khanna
  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

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  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.