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/NCT06039865</url>
    </required_header>
    <id_info>
      <org_study_id>20233750</org_study_id>
      <nct_id>NCT06039865</nct_id>
    </id_info>
    <brief_title>Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial</brief_title>
    <acronym>mPAP</acronym>
    <official_title>Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Greater Los Angeles Healthcare System</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Greater Los Angeles Healthcare System</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive&#xD;
        airway pressure therapy is to test the effects of a new patient-facing consumer&#xD;
        wearable-based program (that involves provision of a consumer wearable that measures oxygen&#xD;
        levels during sleep plus customized weekly reports to participants). The main question is to&#xD;
        learn whether participants' use of positive airway pressure therapy will differ between the&#xD;
        participants who receive the new program immediately versus delayed. Participants assigned to&#xD;
        the delayed program will receive usual care while waiting for the program to begin.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, all patients giving written&#xD;
        informed consent will undergo a screening to determine eligibility for study entry. Patients&#xD;
        who meet the eligibility requirements will be randomized to immediate versus waitlist control&#xD;
        in a 1:1 ratio.&#xD;
  &#xD;
        Our project is at the forefront of consumer wearable research, leveraging the recent&#xD;
        capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover&#xD;
        new ways to promote PAP usage among patients with obstructive sleep apnea.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PAP adherence (minutes)</measure>
      <time_frame>5 weeks</time_frame>
      <description>Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PAP adherence (percent of days used &gt;= 4 hours)</measure>
      <time_frame>5 weeks</time_frame>
      <description>Change in the percent of days PAP was used &gt;= 4 hours</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Obstructive Sleep Apnea</condition>
    <arm_group>
      <arm_group_label>Immediate Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Immediate Intervention</intervention_name>
      <description>Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.</description>
      <arm_group_label>Immediate Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Waitlist control</intervention_name>
      <description>Participants only receive usual care from the sleep center.</description>
      <arm_group_label>Waitlist control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Prescribed PAP therapy from the sleep center for &gt; 1 week&#xD;
  &#xD;
            -  Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator&#xD;
               accounts for &gt; 1 week&#xD;
  &#xD;
            -  Non-adherent with PAP therapy&#xD;
  &#xD;
            -  Willing to continue using current PAP device for 28 days continuously&#xD;
  &#xD;
            -  Have an electronic device compatible with the wearable app&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of heart failure, chronic lung disease, dementia, active substance use&#xD;
               disorder&#xD;
  &#xD;
            -  Use home oxygen&#xD;
  &#xD;
            -  Unstable medical or psychiatric illness&#xD;
  &#xD;
            -  Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)&#xD;
  &#xD;
            -  Planned surgery or hospitalization during study period&#xD;
  &#xD;
            -  Planned extensive travel during study period&#xD;
  &#xD;
            -  History of repeated non-attendance at clinic visits&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Constance H. Fung, MD, MSHS</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Greater Los Angeles Healthcare System</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Constance H. Fung, MD, MSHS</last_name>
      <phone>818 891-7711</phone>
      <phone_ext>39311</phone_ext>
      <email>Constance.Fung@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Erin Der-Mcleod, MSW</last_name>
      <phone>818 891-7711</phone>
      <phone_ext>36067</phone_ext>
      <email>Erin.Der-Mcleod@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>VA Greater Los Angeles Healthcare System</name>
        <address>
          <city>North Hills</city>
          <state>California</state>
          <zip>91343</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael K. Ong, MD</last_name>
        <phone>310-478-3711</phone>
        <phone_ext>42345</phone_ext>
        <email>Michael.Ong2@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Scott E. Krahl, PhD</last_name>
        <phone>(818) 895-5861</phone>
        <email>Scott.Krahl@va.gov</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>VA Greater Los Angeles Healthcare System</investigator_affiliation>
      <investigator_full_name>Constance Fung</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Wearable</keyword>
    <keyword>Pulse oximetry</keyword>
    <keyword>Sleep apnea</keyword>
    <keyword>Treatment adherence</keyword>
    <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>
    </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/NCT06039865
  org study id: 20233750
  nct id: NCT06039865
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive
        airway pressure therapy is to test the effects of a new patient-facing consumer
        wearable-based program (that involves provision of a consumer wearable that measures oxygen
        levels during sleep plus customized weekly reports to participants). The main question is to
        learn whether participants' use of positive airway pressure therapy will differ between the
        participants who receive the new program immediately versus delayed. Participants assigned to
        the delayed program will receive usual care while waiting for the program to begin.
  After being informed about the study and potential risks, all patients giving written
        informed consent will undergo a screening to determine eligibility for study entry. Patients
        who meet the eligibility requirements will be randomized to immediate versus waitlist control
        in a 1:1 ratio.
  
        Our project is at the forefront of consumer wearable research, leveraging the recent
        capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover
        new ways to promote PAP usage among patients with obstructive sleep apnea.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PAP adherence (minutes)
  time frame: 5 weeks
  description: Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).
  measure: PAP adherence (percent of days used >= 4 hours)
  time frame: 5 weeks
  description: Change in the percent of days PAP was used >= 4 hours
  arm group label: Immediate Intervention
  arm group type: Experimental
  description: Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
  arm group label: Waitlist control
  arm group type: Other
  description: Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
  intervention type: Behavioral
  intervention name: Immediate Intervention
  description: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
  arm group label: Immediate Intervention
  intervention type: Behavioral
  intervention name: Waitlist control
  description: Participants only receive usual care from the sleep center.
  arm group label: Waitlist control
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Constance H. Fung, MD, MSHS
  role: Principal Investigator
  affiliation: VA Greater Los Angeles Healthcare System
  last name: Constance H. Fung, MD, MSHS
  phone: 818 891-7711
  phone ext: 39311
  email: Constance.Fung@va.gov
  last name: Erin Der-Mcleod, MSW
  phone: 818 891-7711
  phone ext: 36067
  email: Erin.Der-Mcleod@va.gov
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: VA Greater Los Angeles Healthcare System
  investigator full name: Constance Fung
  investigator title: Principal Investigator
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive