<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03812653</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00147316</org_study_id>
    <secondary_id>1U01NS099043-01A1</secondary_id>
    <nct_id>NCT03812653</nct_id>
  </id_info>
  <brief_title>Sleep for Stroke Management and Recovery Trial</brief_title>
  <acronym>Sleep SMART</acronym>
  <official_title>Sleep for Stroke Management and Recovery Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>FusionHealth LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)&#xD;
      with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA&#xD;
      (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after&#xD;
      the event, and (2) improves stroke outcomes at 3 months in patients who experienced an&#xD;
      ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is&#xD;
      a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to&#xD;
      usual care. The study includes two trials: a prevention study with an embedded recovery&#xD;
      trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded&#xD;
      StrokeNet clinical trials network.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 9, 2019</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality</measure>
    <time_frame>6 months post randomization</time_frame>
    <description>The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Rankin Scale Score</measure>
    <time_frame>3 months post randomization</time_frame>
    <description>Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NIH Stroke Score (NIHSS)</measure>
    <time_frame>3 months post randomization</time_frame>
    <description>Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Montreal Cognitive Assessment (MoCA) Score</measure>
    <time_frame>3 months post randomization</time_frame>
    <description>Cognitive outcome is measured by the Short MoCA. The short MoCA is a 5 minute short version of the Montreal Cognitive Assessment (MoCA). This instrument tests phonemic verbal fluency (1 point), delayed recall (5 points), and orientation (6 points) with a score ranging from 0-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life outcome</measure>
    <time_frame>3 months post randomization</time_frame>
    <description>Quality of life outcome is measured by the shortened Stroke Specific Quality of Life Scale (SS-QOL). The short SS-QOL has 7 domains that include physical function, language, vision, thinking, energy, mood, and role function. There is 1 question from each domain. The 12 item SS-QOL is calculated by averaging the scores of these 12 questions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3062</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Sleep Apnea</condition>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>TIA</condition>
  <condition>Stroke</condition>
  <condition>CPAP</condition>
  <condition>Telemedicine</condition>
  <condition>Home Sleep Apnea Test</condition>
  <condition>Randomized Clinical Trial</condition>
  <condition>Multicenter Trial</condition>
  <arm_group>
    <arm_group_label>Intervention Arm: CPAP with Usual Care.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 months of CPAP plus usual medical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm: Usual Care.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>6 months of usual medical therapy alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CPAP</intervention_name>
    <description>Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.</description>
    <arm_group_label>Intervention Arm: CPAP with Usual Care.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pre-event inability to perform all of own basic ADLs&#xD;
&#xD;
          2. unable to obtain informed consent from subject or legally authorized representative&#xD;
&#xD;
          3. incarcerated&#xD;
&#xD;
          4. known pregnancy&#xD;
&#xD;
          5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy&#xD;
&#xD;
          6. current use of positive airway pressure, or use within one month prior to stroke&#xD;
&#xD;
          7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible&#xD;
&#xD;
          8. severe bullous lung disease&#xD;
&#xD;
          9. history of prior spontaneous pneumothorax or current pneumothorax&#xD;
&#xD;
         10. hypotension requiring current treatment with pressors (can enroll later if this&#xD;
             resolves)&#xD;
&#xD;
         11. other specific medical circumstances that conceivably, in the opinion of the site PI,&#xD;
             could render the patient at risk of harm from use of CPAP&#xD;
&#xD;
         12. massive epistaxis or previous history of massive epistaxis&#xD;
&#xD;
         13. cranial surgery or head trauma within the past 6 months, with known or possible CSF&#xD;
             leak or pneumocephalus&#xD;
&#xD;
         14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet&#xD;
             been replaced), or any other recent bone removal procedure for relief of intracranial&#xD;
             pressure&#xD;
&#xD;
         15. current receipt of oxygen supplementation &gt;4 liters per minute&#xD;
&#xD;
         16. current contact, droplet, respiratory/airborne precautions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Devin Brown, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald Chervin, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kayla Novitski, MPH, CCRP</last_name>
    <phone>734-615-2006</phone>
    <email>kcgossel@med.umich.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joelle Sickler, MSN, CCRC, CCRA</last_name>
    <email>sicklejb@ucmail.uc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tammy Davis</last_name>
      <email>trdavis@uabmc.edu</email>
    </contact>
    <investigator>
      <last_name>Soo Young Kwon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chandler Regional Medical Center</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allegra Sahelian</last_name>
      <email>allegra.sahelian900@commonspirit.org</email>
    </contact>
    <investigator>
      <last_name>Dan Joseph Capampangan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmen Galaz</last_name>
      <email>cgalaz@arizona.edu</email>
    </contact>
    <investigator>
      <last_name>Joyce Lee Lannotti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dignity Health - St. Joseph's Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Megan Briggs</last_name>
      <email>megan.briggs900@commonspirit.org</email>
    </contact>
    <investigator>
      <last_name>Supreet Kaur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Ruiz Morales</last_name>
      <email>RuizMorales.Stephanie@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Oana Dumitrascu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>TMC Healthcare</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Marsh</last_name>
      <email>mary.marsh@tmcaz.com</email>
    </contact>
    <investigator>
      <last_name>David Teeple, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner- University Medical Center Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shriya Kavathia</last_name>
      <email>shriyakavathia@arizona.edu</email>
    </contact>
    <investigator>
      <last_name>Bruce Coull, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy San Juan Medical Center</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danielle Hornbuckle</last_name>
      <email>danielle.hornbuckle@commonspirit.org</email>
    </contact>
    <investigator>
      <last_name>Lucian Maidan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rancho Los Amigos National Rehabilitation Center</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marielena Meza</last_name>
      <email>marielenam@ranchoresearch.org</email>
    </contact>
    <investigator>
      <last_name>Susan Shaw, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Scripps Memorial</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sandra Sanchez</last_name>
      <email>Sanchez.Sandra2@scrippshealth.org</email>
    </contact>
    <investigator>
      <last_name>Mary Kalafut, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSD Health La Jolla</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theresa McQuaid</last_name>
      <email>tmcquaid@ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Dawn Meyer, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vicki Manoukian</last_name>
      <email>vicki.manoukian@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Konrad Schlick, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daisy Mercado</last_name>
      <email>DMercado@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Alon Avidan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashima Sharma</last_name>
      <email>Ashima.X.Sharma@kp.org</email>
    </contact>
    <investigator>
      <last_name>Prasanth Manthena, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Doctors Medical Center of Modesto</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95355</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dharati Trivedi</last_name>
      <email>Dharati.trivedi@tenethealth.com</email>
    </contact>
    <investigator>
      <last_name>James Jaffe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCLA Kaiser Fontana</name>
      <address>
        <city>Ontario</city>
        <state>California</state>
        <zip>91761</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanessa Audea</last_name>
      <email>vanessa@audea@kp.org</email>
    </contact>
    <investigator>
      <last_name>Conrad Liang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josue Prado</last_name>
      <email>josuep2@hs.uci.edu</email>
    </contact>
    <investigator>
      <last_name>Masaki Nagamine, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Casa Colina</name>
      <address>
        <city>Pomona</city>
        <state>California</state>
        <zip>91767</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeanette Gumarang</last_name>
      <email>jgumarang@casacolina.org</email>
    </contact>
    <investigator>
      <last_name>Caroline Schnakers, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Sevilla</last_name>
      <email>amdiazsevilla@ucdavis.edu</email>
    </contact>
    <investigator>
      <last_name>Kwan Ng, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSD Medical Center - Hillcrest Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theresa McQuaid</last_name>
      <email>tmcquaid@ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>Dawn Meyer, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSF Helen Diller Medical Center at Parnassus Heights</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eliot Lee</last_name>
      <email>Eliot.Lee@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Wade Smith, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orange County Global Medical Center</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marylinn Torres</last_name>
      <email>Marylinntorres@kpchealth.com</email>
    </contact>
    <investigator>
      <last_name>John Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Olive View- UCLA Medical Center</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Molly Misuraca</last_name>
      <email>mmisuraca@dhs.lacounty.gov</email>
    </contact>
    <investigator>
      <last_name>Neal Rao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Muir Medical Center- Walnut Creek Campus</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melenie Aaron</last_name>
      <email>Melenie.aaron@johnmuirhealth.com</email>
    </contact>
    <investigator>
      <last_name>Ok-Kyung Kim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital and Medical Center</name>
      <address>
        <city>Grand Junction</city>
        <state>Colorado</state>
        <zip>81501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Bertrand</last_name>
      <email>Lisa.Bertrand@sclhealth.org</email>
    </contact>
    <investigator>
      <last_name>Logan Mcdaneld, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bridgeport Hospital</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerie Assalone</last_name>
      <email>valeria.assalone@bpthosp.org</email>
    </contact>
    <investigator>
      <last_name>Armand Wolff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Grenier</last_name>
      <email>laura.grenier@hhchealth.org</email>
    </contact>
    <investigator>
      <last_name>Francoise Roux, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale-New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Radu Radulescu</last_name>
      <email>radu.radulescu@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Klar Yaggi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>George Washington University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Preethy Feit</last_name>
      <email>pfeit@mfa.gwu.edu</email>
    </contact>
    <investigator>
      <last_name>Fernando Mayor Basto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UF Health Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neringa May</last_name>
      <email>neringa.may@neurology.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Anna Khanna, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brooks Rehabilitation Hospital</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Taisiya Matev</last_name>
      <email>Taisiya.Matev@Brooksrehab.org</email>
    </contact>
    <investigator>
      <last_name>Kenneth Ngo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Serat</last_name>
      <email>serat.joanna@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Brynn Dredla, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Escobar</last_name>
      <email>a.escobar1@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Jose Romano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Escobar</last_name>
      <email>a.escobar1@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Jose Romano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josette Elysee</last_name>
      <email>JosetteE@baptisthealth.net</email>
    </contact>
    <investigator>
      <last_name>Felipe De Los Rios La Rosa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hospital</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Flora Arevalo</last_name>
      <email>farevalo@intercoastalmedical.com</email>
    </contact>
    <investigator>
      <last_name>Mauricio Concha, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marla Hairson</last_name>
      <email>hairston@usf.edu</email>
    </contact>
    <investigator>
      <last_name>William Scott Burgin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henna McCoy</last_name>
      <email>Henna_R_McCoy@rush.edu</email>
    </contact>
    <investigator>
      <last_name>Laurel Cherian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Illinois Hospital and Health Sciences System</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maureen Hillmann</last_name>
      <email>hillmann@uic.edu</email>
    </contact>
    <investigator>
      <last_name>Gabriela Trifan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samantha Jankowski</last_name>
      <email>sjankowski@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Kenneth Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60513</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Chavez</last_name>
      <email>mchavez11@luc.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Schneck, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Medical Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61603</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashwath Ravisankar</last_name>
      <email>Ashwath.R.Ravisankar@osfhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Arun Talkad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Lokaitis</last_name>
      <email>blokaitis@siumed.edu</email>
    </contact>
    <investigator>
      <last_name>Hesham Allam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heena Olade</last_name>
      <email>heena-olalde@uiowa.edu</email>
    </contact>
    <investigator>
      <last_name>Mark Dyken, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Albert B. Chandler Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Arnold</last_name>
      <email>pat.arnold@uky.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Norton HealthCare</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debbie Cobb</last_name>
      <email>Debbie.Cobb@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>David Hasselbacher, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center - Main Campus</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariah Delaune</last_name>
      <email>mariah.delaune@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>Richard Zweifler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Health Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Norma Phillips</last_name>
      <email>nphil1@lsuhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Oleg Chernyshev, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bisola Amoudu</last_name>
      <email>BAmodu@som.umaryland.edu</email>
    </contact>
    <investigator>
      <last_name>Seemant Chaturvedi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Lynch</last_name>
      <email>glynch@tuftsmedicalcenter.org</email>
    </contact>
    <investigator>
      <last_name>Lester Y Young, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rhiana Carr</last_name>
      <email>racarr@mgh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>James Mojica, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Sugg</last_name>
      <email>esugg@bwh.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Milena Pavlova, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Marchina</last_name>
      <email>smarchin@bidmc.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Jennifer Dearborn-Tomazos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baystate Health</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sirisha Nouduri</last_name>
      <email>sirisha.nouduri@baystatehealth.org</email>
    </contact>
    <investigator>
      <last_name>Gottfried Schlaug, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Detroit Receiving Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Jia</last_name>
      <email>xjia@med.wayne.edu</email>
    </contact>
    <investigator>
      <last_name>Kumar Rajamani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teresa Wiegand</last_name>
      <email>TWIEGAN1@hfhs.org</email>
    </contact>
    <investigator>
      <last_name>Angelos Katramados, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McLaren Flint</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marci Roberts</last_name>
      <email>marci.roberts@mclaren.org</email>
    </contact>
    <investigator>
      <last_name>Mahmoud Rayes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bronson Methodist Hospital</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49008</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Philipp Petrick</last_name>
      <email>Emily.Petrick@wmed.edu</email>
    </contact>
    <investigator>
      <last_name>Mark Goetting, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Saint Marys Campus</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cameron Hunter</last_name>
      <email>Hunter.Cameron@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Eugene Scharf, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Cloud/Centracare Health</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawn Bauerly-Pieper</last_name>
      <email>dawn.bauerly-pieper@centracare.com</email>
    </contact>
    <investigator>
      <last_name>Muhammad Fareed K Suri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Wigglesworth</last_name>
      <email>ajwigglesworth@umc.edu</email>
    </contact>
    <investigator>
      <last_name>Dani Choufani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Kennish</last_name>
      <email>ckennish@saint-lukes.org</email>
    </contact>
    <investigator>
      <last_name>Karin Olds, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Wolford</last_name>
      <email>angelaw@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Eric Landsness, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cox Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Ratcliff</last_name>
      <email>jessica.ratcliff@coxhealth.com</email>
    </contact>
    <investigator>
      <last_name>Benjamin Lisle, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irena Kovacevic</last_name>
      <email>irena.kovacevic@unmc.edu</email>
    </contact>
    <investigator>
      <last_name>Pierre Fayad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Hospital</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jacquelyn Morales</last_name>
      <email>JSMorales@salud.unm.edu</email>
    </contact>
    <investigator>
      <last_name>Michel Torbey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oleg Otlivanchik</last_name>
      <email>ootlivan@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Kathryn Kirchoff-Torres, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maryna Mootoo</last_name>
      <email>mmootoo@maimonidesmed.org</email>
    </contact>
    <investigator>
      <last_name>Qingliang Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Langone Brooklyn</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11220</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Cotrina</last_name>
      <email>Maria.Cotrina@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Aaron Lord, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Buffalo General Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annemarie Crumlish</last_name>
      <email>ac35@buffalo.edu</email>
    </contact>
    <investigator>
      <last_name>Amit Kandal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirendra Pasram</last_name>
      <email>kpasram1@northwell.edu</email>
    </contact>
    <investigator>
      <last_name>Rohan Arora, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Langone -Tish Hospital Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yasmeen Mahady</last_name>
      <email>Yasmeen.Mahady@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Koto Ishida, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Velazquez</last_name>
      <email>agv2113@columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Joshua Willey, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Strong Memorial Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Barone</last_name>
      <email>Joseph_Barone@URMC.Rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Curtis Benesch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Staten Island University Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brandon Dilluvio</last_name>
    </contact>
    <investigator>
      <last_name>Umran Ugur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Suny Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lena Deb</last_name>
      <email>debl@upstate.edu</email>
    </contact>
    <investigator>
      <last_name>Julius Gene Latorre, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Helms</last_name>
      <email>Anna.M.Helms@atriumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Rahul Karamchandani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carolinas Rehab Northeast</name>
      <address>
        <city>Concord</city>
        <state>North Carolina</state>
        <zip>28025</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Thompson</last_name>
      <email>Kimberley.Thompson@atriumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Nicole Rup, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guilford Neurologic Associates, Inc</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jamil Admed</last_name>
      <email>jamil.ahmed@gnr.clinic</email>
    </contact>
    <investigator>
      <last_name>Pramod Sethi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Krystal Schmidt</last_name>
      <email>kschmidt@wakehealth.edu</email>
    </contact>
    <investigator>
      <last_name>Cheryl Bushnell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ranjaka Gunawardena</last_name>
      <email>gunawad@ucmail.uc.edu</email>
    </contact>
    <investigator>
      <last_name>Karthik Kanagarajan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ranjaka Gunawardena</last_name>
      <email>gunawad@ucmail.uc.edu</email>
    </contact>
    <investigator>
      <last_name>Natalie Kreitzer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UH Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>11100</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Andrews</last_name>
      <email>Mary.Andrews@UHhospitals.org</email>
    </contact>
    <investigator>
      <last_name>Sophia Sundararajan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Smith</last_name>
      <email>smithb18@ccf.org</email>
    </contact>
    <investigator>
      <last_name>Zeshaun Khawaja, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>OSU Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luke Herren</last_name>
      <email>luke.herren@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Sushil Lakhani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Promedica Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melanie Pakulski</last_name>
      <email>Melanie.Pakulski@ProMedica.org;</email>
    </contact>
    <investigator>
      <last_name>Mouhammad Jumaa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Chester Hospital</name>
      <address>
        <city>West Chester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ranjaka Gunawardena</last_name>
      <email>gunawad@ucmail.uc.edu</email>
    </contact>
    <investigator>
      <last_name>Natalie Kreitzer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. John Health System</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elvis Tamo</last_name>
      <email>elvis.tamo@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Rahul Rahangdale, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence St. Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelsey Walker</last_name>
      <email>Kelsey.Walker@providence.org</email>
    </contact>
    <investigator>
      <last_name>Biggya Sapkota, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia Rohret</last_name>
      <email>rohret@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Wayne Clark, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Hospital Bethlehem Campus</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danielle Schneider</last_name>
      <email>Danielle.Schneider@sluhn.org</email>
    </contact>
    <investigator>
      <last_name>Daniel Ackerman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger Clinic</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Blockus</last_name>
      <email>alblockus@geisinger.edu</email>
    </contact>
    <investigator>
      <last_name>Clemens Schirmer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia Christman</last_name>
      <email>ochristman@pennstatehealth.psu.edu</email>
    </contact>
    <investigator>
      <last_name>Raymond Reichwein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nichole Gallatti</last_name>
      <email>Nichole.gallatti@uphs.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Steven Messe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra Combs</last_name>
      <email>Sandra.combs@tuhs.temple.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Mullen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Presbyterian Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Weimer</last_name>
      <email>weimerjm@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah Wondisford, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Palmetto Health Richland</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Phil Fleming</last_name>
      <email>Phil.Fleming2@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Souvik Sen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Greenville Memorial Hospital</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reilly Leonard</last_name>
      <email>Reilly.Leonard@PrismaHealth.org</email>
    </contact>
    <investigator>
      <last_name>Neel Shah, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Avera Research Institute</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cassidy Kaiser</last_name>
      <email>Cassidy.Kaiser@avera.org</email>
    </contact>
    <investigator>
      <last_name>William Rossing, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Methodist University</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Quentin Thacker</last_name>
      <email>qthacker@uthsc.edu</email>
    </contact>
    <investigator>
      <last_name>Balaji Krishnaiah, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Institute of Rehabilitation</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Baltz</last_name>
      <email>Sara.Baltz@BSWHealth.org</email>
    </contact>
    <investigator>
      <last_name>Chad Swank, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ariana Hernandez</last_name>
      <email>Ariana.Victoria.AquinoHernandez@uth.tmc.edu</email>
    </contact>
    <investigator>
      <last_name>Anjail Sharrief, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsay Bosh</last_name>
      <email>lindsay.bosh@imail.org</email>
    </contact>
    <investigator>
      <last_name>Paul Johnson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Utah Healthcare</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia Darling</last_name>
      <email>julia.darling@hsc.utah.edu</email>
    </contact>
    <investigator>
      <last_name>Jana Wold, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Vermont Medical Center Main Campus</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christopher Commichau, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UVA Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Allison Ramsey</last_name>
      <email>agr5nj@uvahealth.org</email>
    </contact>
    <investigator>
      <last_name>Nina Solenski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Madarasz</last_name>
      <email>Laura.madarasz@inova.org</email>
    </contact>
    <investigator>
      <last_name>Saqib Chaudhry, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Machuca</last_name>
      <email>daniel.machuca@virginiamason.org</email>
    </contact>
    <investigator>
      <last_name>Fatima Milfred, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brooke Haines</last_name>
      <email>bmh32@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Sandeep Khot, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ruby Memorial Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jay Sherman</last_name>
      <email>shermanj@wvumedicine.org</email>
    </contact>
    <investigator>
      <last_name>Mouhannad Azzouz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gundersen Lutheran Medical Foundation</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kim Halverson</last_name>
      <email>kehalver@gundersenhealth.org</email>
    </contact>
    <investigator>
      <last_name>Mark Domroese, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin University Hospital</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sima Sayyahmelli</last_name>
      <email>sayyahmelli@neurosurgery.wisc.edu</email>
    </contact>
    <investigator>
      <last_name>Robert Dempsey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Devin L. Brown, MD</investigator_full_name>
    <investigator_title>Professor of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will comply with the NIH Data Sharing Policy, Policy on the Dissemination of NIH-Funded Clinical Trial Information, the Clinical Trials Registration and Results Information Submission rule, and StrokeNet SOP on Network Data Sharing Policy. NDMC statisticians will generate data files from each data table and in compliance with HIPAA regulations each table will be de-identified. A minimum number of derived variables necessary to reproduce the primary analysis will be created. Within a year from acceptance of the primary manuscript or no later than two years from database lock, the public-use data sets will be submitted to the NINDS data repository along with final version of the study protocol, data dictionary and a user guide. Data along with signals from sleep apnea recordings will be submitted to the NHLBI National Sleep Research Resource.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03812653
org study id: HUM00147316
secondary id: 1U01NS099043-01A1
nct id: NCT03812653
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
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.
measure: Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
time frame: 6 months post randomization
description: The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality
measure: Modified Rankin Scale Score
time frame: 3 months post randomization
description: Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).
measure: NIH Stroke Score (NIHSS)
time frame: 3 months post randomization
description: Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.
measure: Short Montreal Cognitive Assessment (MoCA) Score
time frame: 3 months post randomization
description: Cognitive outcome is measured by the Short MoCA. The short MoCA is a 5 minute short version of the Montreal Cognitive Assessment (MoCA). This instrument tests phonemic verbal fluency (1 point), delayed recall (5 points), and orientation (6 points) with a score ranging from 0-12.
measure: Quality of Life outcome
time frame: 3 months post randomization
description: Quality of life outcome is measured by the shortened Stroke Specific Quality of Life Scale (SS-QOL). The short SS-QOL has 7 domains that include physical function, language, vision, thinking, energy, mood, and role function. There is 1 question from each domain. The 12 item SS-QOL is calculated by averaging the scores of these 12 questions.
arm group label: Intervention Arm: CPAP with Usual Care.
arm group type: Experimental
description: 6 months of CPAP plus usual medical therapy.
arm group label: Control Arm: Usual Care.
arm group type: No Intervention
description: 6 months of usual medical therapy alone.
intervention type: Device
intervention name: CPAP
description: Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
arm group label: Intervention Arm: CPAP with Usual Care.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Devin Brown, MD, MS
role: Principal Investigator
affiliation: University of Michigan
last name: Ronald Chervin, MD, MS
role: Principal Investigator
affiliation: University of Michigan
last name: Kayla Novitski, MPH, CCRP
phone: 734-615-2006
email: kcgossel@med.umich.edu
last name: Joelle Sickler, MSN, CCRC, CCRA
email: sicklejb@ucmail.uc.edu
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country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Devin L. Brown, MD
investigator title: Professor of Neurology
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: Yes
ipd description: We will comply with the NIH Data Sharing Policy, Policy on the Dissemination of NIH-Funded Clinical Trial Information, the Clinical Trials Registration and Results Information Submission rule, and StrokeNet SOP on Network Data Sharing Policy. NDMC statisticians will generate data files from each data table and in compliance with HIPAA regulations each table will be de-identified. A minimum number of derived variables necessary to reproduce the primary analysis will be created. Within a year from acceptance of the primary manuscript or no later than two years from database lock, the public-use data sets will be submitted to the NINDS data repository along with final version of the study protocol, data dictionary and a user guide. Data along with signals from sleep apnea recordings will be submitted to the NHLBI National Sleep Research Resource.