xml: <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/NCT06029959</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00016907</org_study_id>
      <secondary_id>1R01HL164394-01A1</secondary_id>
      <nct_id>NCT06029959</nct_id>
    </id_info>
    <brief_title>Stroke and CPAP Outcome Study 3</brief_title>
    <acronym>SCOUTS3</acronym>
    <official_title>Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases&#xD;
        the risk of stroke and is common in people who have had a stroke, present in about 2/3 of&#xD;
        stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The&#xD;
        question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve&#xD;
        use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during&#xD;
        intensive stroke rehabilitation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In an initial single-arm study, participants with stroke will be tested for OSA and treated&#xD;
        with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month&#xD;
        treatment period. Multiple behavioral interventions will be used to improve CPAP use,&#xD;
        including intensive CPAP technical support, motivational enhancement therapy, and phone and&#xD;
        mobile health automated support. The multicomponent behavioral intervention will be optimized&#xD;
        to improve CPAP adherence with the engagement and input of stroke survivors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>CPAP Adherence</measure>
      <time_frame>From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation</time_frame>
      <description>Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stroke Severity</measure>
      <time_frame>From in-person assessment at enrollment to the end of inpatient rehabilitation</time_frame>
      <description>National Institutes of Health Stroke Scale (NIHSS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Disability</measure>
      <time_frame>From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment</time_frame>
      <description>Modified Rankin Score-9 Questions (mRS-9Q)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>CPAP partner burden</measure>
      <time_frame>At follow-up timepoint of 90 +/- 14 days after enrollment</time_frame>
      <description>Zarit Burden Interview</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Ischemic Stroke</condition>
    <condition>Intra Cerebral Hemorrhage</condition>
    <condition>Obstructive Sleep Apnea</condition>
    <condition>Adherence, Treatment</condition>
    <condition>Motivation</condition>
    <arm_group>
      <arm_group_label>SCOUTS3 Optimization Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Continuous positive airway pressure (CPAP)</intervention_name>
      <description>Eligible participants with a diagnosis of OSA will be set up with autotitrating CPAP by the study's sleep technologist. The CPAP device includes an auto-titrator that adjusts the delivered pressure between 5 to 15 cm of water to eliminate obstructive events.</description>
      <arm_group_label>SCOUTS3 Optimization Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CPAP technical support intervention</intervention_name>
      <description>SCOUTS 3 sleep technologists (ST) will make mask type/size or device adjustments, as needed, and provide training to participants and CPAP partners to improve skills involved with mask placement and device maintenance. For participants with non-acceptance of CPAP over the first night, a standardized desensitization program will be implemented. Persistent problems with CPAP use or mask fit, or any high residual respiratory events will be discussed between the sleep technologist and the study's board-certified sleep medicine physician.</description>
      <arm_group_label>SCOUTS3 Optimization Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Motivational Enhancement Therapy (MET)</intervention_name>
      <description>In-person Motivational Enhancement Therapy (MET) sessions by a trained sleep coach will occur within a week of starting CPAP and, with permission, conducted with a CPAP partner, when available. The MET session recordings will be uploaded into the HIPAA compliant Lyssn platform for evaluation, including feedback to the sleep coach. The goal will be 5 total MET sessions, either in-person or by phone, spanning the inpatient and then outpatient settings.</description>
      <arm_group_label>SCOUTS3 Optimization Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobile Health intervention</intervention_name>
      <description>Study participants will be assisted in registering for and trained on the ResMed myAir app. Participants will also receive mobile health messages based on Self-Determination Theory.</description>
      <arm_group_label>SCOUTS3 Optimization Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Admitted to inpatient rehabilitation unit at University of Washington (UW)&#xD;
  &#xD;
            -  Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal&#xD;
               hemorrhage within past 30 days&#xD;
  &#xD;
            -  Person providing consent (patient or legally authorized representative) able to be&#xD;
               consented in English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to obtain informed consent from participant or surrogate&#xD;
  &#xD;
            -  Incarcerated&#xD;
  &#xD;
            -  Known pregnancy&#xD;
  &#xD;
            -  Current mechanical ventilation, tracheostomy or supplemental oxygen use &gt; 4L/min&#xD;
  &#xD;
            -  Current use of positive airway pressure or use within 14 days prior to stroke&#xD;
  &#xD;
            -  History of pneumothorax, bullous emphysema or other serious co-morbid conditions which&#xD;
               limit CPAP use&#xD;
  &#xD;
            -  Stroke related to tumors, vascular malformations or subarachnoid hemorrhage&#xD;
  &#xD;
            -  Active use of sedative drugs that can interfere with testing for obstructive sleep&#xD;
               apnea (OSA)&#xD;
  &#xD;
            -  Anticipated inpatient rehabilitation length of stay &lt; 3 nights&#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>Sandeep Khot, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Devin Brown, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sandeep Khot, MD, MPH</last_name>
      <phone>206-744-3251</phone>
      <email>skhot@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98122</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sandeep Khot, MD, MPH</last_name>
        <email>skhot@uw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://reporter.nih.gov/search/b05ZXayvqUCz6wIm20U-rw/project-details/10658404</url>
      <description>NIH Reporter</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Sandeep Khot</investigator_full_name>
      <investigator_title>Professor, School of Medicine</investigator_title>
    </responsible_party>
    <keyword>behavioral therapy</keyword>
    <keyword>continuous positive airway pressure</keyword>
    <keyword>rehabilitation therapy</keyword>
    <keyword>stroke recovery</keyword>
    <keyword>self determination</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
      <mesh_term>Cerebral Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029959
  org study id: STUDY00016907
  secondary id: 1R01HL164394-01A1
  nct id: NCT06029959
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases
        the risk of stroke and is common in people who have had a stroke, present in about 2/3 of
        stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The
        question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve
        use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during
        intensive stroke rehabilitation.
  In an initial single-arm study, participants with stroke will be tested for OSA and treated
        with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month
        treatment period. Multiple behavioral interventions will be used to improve CPAP use,
        including intensive CPAP technical support, motivational enhancement therapy, and phone and
        mobile health automated support. The multicomponent behavioral intervention will be optimized
        to improve CPAP adherence with the engagement and input of stroke survivors.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: CPAP Adherence
  time frame: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation
  description: Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months
  measure: Stroke Severity
  time frame: From in-person assessment at enrollment to the end of inpatient rehabilitation
  description: National Institutes of Health Stroke Scale (NIHSS)
  measure: Functional Disability
  time frame: From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment
  description: Modified Rankin Score-9 Questions (mRS-9Q)
  measure: CPAP partner burden
  time frame: At follow-up timepoint of 90 +/- 14 days after enrollment
  description: Zarit Burden Interview
  arm group label: SCOUTS3 Optimization Arm
  arm group type: Experimental
  description: In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.
  intervention type: Device
  intervention name: Continuous positive airway pressure (CPAP)
  description: Eligible participants with a diagnosis of OSA will be set up with autotitrating CPAP by the study's sleep technologist. The CPAP device includes an auto-titrator that adjusts the delivered pressure between 5 to 15 cm of water to eliminate obstructive events.
  arm group label: SCOUTS3 Optimization Arm
  intervention type: Behavioral
  intervention name: CPAP technical support intervention
  description: SCOUTS 3 sleep technologists (ST) will make mask type/size or device adjustments, as needed, and provide training to participants and CPAP partners to improve skills involved with mask placement and device maintenance. For participants with non-acceptance of CPAP over the first night, a standardized desensitization program will be implemented. Persistent problems with CPAP use or mask fit, or any high residual respiratory events will be discussed between the sleep technologist and the study's board-certified sleep medicine physician.
  arm group label: SCOUTS3 Optimization Arm
  intervention type: Behavioral
  intervention name: Motivational Enhancement Therapy (MET)
  description: In-person Motivational Enhancement Therapy (MET) sessions by a trained sleep coach will occur within a week of starting CPAP and, with permission, conducted with a CPAP partner, when available. The MET session recordings will be uploaded into the HIPAA compliant Lyssn platform for evaluation, including feedback to the sleep coach. The goal will be 5 total MET sessions, either in-person or by phone, spanning the inpatient and then outpatient settings.
  arm group label: SCOUTS3 Optimization Arm
  intervention type: Behavioral
  intervention name: Mobile Health intervention
  description: Study participants will be assisted in registering for and trained on the ResMed myAir app. Participants will also receive mobile health messages based on Self-Determination Theory.
  arm group label: SCOUTS3 Optimization Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sandeep Khot, MD, MPH
  role: Principal Investigator
  affiliation: University of Washington
  last name: Devin Brown, MD, MS
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Sandeep Khot, MD, MPH
  phone: 206-744-3251
  email: skhot@uw.edu
  facility: 
  contact: 
  country: United States
  url: http://reporter.nih.gov/search/b05ZXayvqUCz6wIm20U-rw/project-details/10658404
  description: NIH Reporter
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Sandeep Khot
  investigator title: Professor, School of Medicine
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Hemorrhage
  mesh term: Hemorrhage