<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/NCT04500327</url>
  </required_header>
  <id_info>
    <org_study_id>DHT-20-04-01</org_study_id>
    <nct_id>NCT04500327</nct_id>
  </id_info>
  <brief_title>An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy</brief_title>
  <official_title>An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate the usability and suitability of the Drive app (app&#xD;
      under test) to measure sleep parameters during CPAP use.&#xD;
&#xD;
      This is a prospective, non-randomized, single arm exploratory study without blinding.&#xD;
&#xD;
      Current users of CPAP therapy will be recruited for this study and will be provided with a&#xD;
      smartphone (app under test installed) and a non-contact motion sensor in their home&#xD;
      environment. These devices will measure sleep metrics such as sleep stages and breathing&#xD;
      metrics that may be associated with sleep disordered breathing. Usage and setup instructions&#xD;
      will be provided for the study.&#xD;
&#xD;
      Participants will contribute up to 7 overnight recordings in the home environment and will&#xD;
      complete daily questionnaires detailing their experience.&#xD;
&#xD;
      The study may be completed in two distinct phases, with an analysis performed after each&#xD;
      phase. Each phase is expected to last up to six weeks with the overall study duration taking&#xD;
      up to 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study may be completed in two distinct phases, with an analysis performed after each&#xD;
      phase.&#xD;
&#xD;
      Phase 1 (Exploratory): A minimum of 10 and up to 12 participants will be recruited to&#xD;
      identify any issues in using the app when used in conjunction with CPAP therapy (e.g. missed&#xD;
      signals, inappropriate classification of breathing signals).&#xD;
&#xD;
      Phase 2 (Iterative Updates): Where changes to the algorithm or user interface are required,&#xD;
      an additional 30 and up to 35 participants may be tested to provide design confidence.&#xD;
      Conversely, if substantial issues are experienced and the time and effort required to address&#xD;
      the issues is sufficiently large, the study may terminate before completion of phase 2.&#xD;
&#xD;
      Each phase is expected to last up to six weeks with the overall study duration taking up to&#xD;
      12 months.&#xD;
&#xD;
      Participants will be required to visit ResMed twice. The first visit will involve briefing of&#xD;
      the study, consent form signatures, briefing on trial equipment and setup/usage instructions.&#xD;
      The second (last) visit will involve going through the daily questionnaires with&#xD;
      participants, collecting trial equipment and providing reimbursement for the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Identify any failures when using the Drive app for users of CPAP therapy</measure>
    <time_frame>12 months (includes Phase 1 and Phase 2 and interim data analysis)</time_frame>
    <description>This will be based on:&#xD;
Subjective data from daily questionnaires sent out to participants&#xD;
Comparison between Drive app data with the non contact motion sensor and CPAP data&#xD;
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.&#xD;
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate usability of the Drive app</measure>
    <time_frame>12 months (includes Phase 1 and Phase 2 and interim data analysis)</time_frame>
    <description>This will be based on subjective data from daily questionnaires sent out to participants.&#xD;
This data will be captured from comments by the participants in the daily questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare subjective sleep quality data with data generated on the app.</measure>
    <time_frame>12 months (includes Phase 1 and Phase 2 and interim data analysis)</time_frame>
    <description>This will be based on subjective data from daily questionnaires sent out to participants.&#xD;
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the Drive app sleep data to data from the reference devices.</measure>
    <time_frame>12 months (includes Phase 1 and Phase 2 and interim data analysis)</time_frame>
    <description>Analyses will be performed to compare the Drive app data with the non contact motion sensor and CPAP device.&#xD;
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>CPAP users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Drive app will be used by CPAP users to identify any major issues with the usability and functionality of the app when used with CPAP therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Drive app</intervention_name>
    <description>The Drive app will be used to monitor sleep metrics for users of CPAP therapy.</description>
    <arm_group_label>CPAP users</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non contact motion sensor</intervention_name>
    <description>The non contact motion sensor will be used as a reference to the Drive app i.e. Drive app overnight recordings will be compared to the non contact motion sensor overnight recordings.</description>
    <arm_group_label>CPAP users</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants willing to give written informed consent&#xD;
&#xD;
          -  Participants who can read and comprehend English&#xD;
&#xD;
          -  Participants who ≥ 18 years of age&#xD;
&#xD;
          -  Participants established on CPAP therapy for the treatment of OSA for ≥ 6 months&#xD;
&#xD;
          -  Participants who are able to set up the trial devices (ideally on a bedside table)&#xD;
             with the following criteria:&#xD;
&#xD;
               -  Trial devices must be 10 cm higher than the mattress&#xD;
&#xD;
               -  Approx. 40 cm from the person's chest in bed&#xD;
&#xD;
          -  Participants that have access to WI-FI in their home environment&#xD;
&#xD;
          -  Participants who can trial the device for up to 7 nights&#xD;
&#xD;
          -  *Participants who have been compliant (average of ≥4 hours of usage) to therapy for up&#xD;
             to 7 nights of use&#xD;
&#xD;
               -  Note: the most recent consecutive 7 nights within the last 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants using Bilevel flow generators&#xD;
&#xD;
          -  Participants who are or may be pregnant, breastfeeding or within 6 weeks postpartum&#xD;
             (which are known to cause significant sleep disruption)&#xD;
&#xD;
          -  Participants with a preexisting lung disease/ condition that would predispose them to&#xD;
             pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (&lt; 2years)&#xD;
             case of pneumonia or lung infection; lung injury.&#xD;
&#xD;
          -  Participants believed to be unsuitable for inclusion by the researcher&#xD;
&#xD;
          -  *Participants using one of the following devices or Apps during the research period,&#xD;
             or any other sleep tracking devices: SPlus, SleepScore app, SleepScore Max.&#xD;
&#xD;
               -  Note: If the participant uses the devices or apps above and they agree to&#xD;
                  delete/not use them during study period, they can be included in the study.&#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_contact>
    <last_name>Neha Banodkar</last_name>
    <phone>(02) 8884 2656</phone>
    <email>neha.banodkar@resmed.com.au</email>
  </overall_contact>
  <location>
    <facility>
      <name>ResSleep</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2153</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neha Banodkar</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04500327
org study id: DHT-20-04-01
nct id: NCT04500327
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the usability and suitability of the Drive app (app
      under test) to measure sleep parameters during CPAP use.

      This is a prospective, non-randomized, single arm exploratory study without blinding.

      Current users of CPAP therapy will be recruited for this study and will be provided with a
      smartphone (app under test installed) and a non-contact motion sensor in their home
      environment. These devices will measure sleep metrics such as sleep stages and breathing
      metrics that may be associated with sleep disordered breathing. Usage and setup instructions
      will be provided for the study.

      Participants will contribute up to 7 overnight recordings in the home environment and will
      complete daily questionnaires detailing their experience.

      The study may be completed in two distinct phases, with an analysis performed after each
      phase. Each phase is expected to last up to six weeks with the overall study duration taking
      up to 12 months.
The study may be completed in two distinct phases, with an analysis performed after each
      phase.

      Phase 1 (Exploratory): A minimum of 10 and up to 12 participants will be recruited to
      identify any issues in using the app when used in conjunction with CPAP therapy (e.g. missed
      signals, inappropriate classification of breathing signals).

      Phase 2 (Iterative Updates): Where changes to the algorithm or user interface are required,
      an additional 30 and up to 35 participants may be tested to provide design confidence.
      Conversely, if substantial issues are experienced and the time and effort required to address
      the issues is sufficiently large, the study may terminate before completion of phase 2.

      Each phase is expected to last up to six weeks with the overall study duration taking up to
      12 months.

      Participants will be required to visit ResMed twice. The first visit will involve briefing of
      the study, consent form signatures, briefing on trial equipment and setup/usage instructions.
      The second (last) visit will involve going through the daily questionnaires with
      participants, collecting trial equipment and providing reimbursement for the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Identify any failures when using the Drive app for users of CPAP therapy
time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
description: This will be based on:
Subjective data from daily questionnaires sent out to participants
Comparison between Drive app data with the non contact motion sensor and CPAP data
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
measure: Evaluate usability of the Drive app
time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
description: This will be based on subjective data from daily questionnaires sent out to participants.
This data will be captured from comments by the participants in the daily questionnaires.
measure: Compare subjective sleep quality data with data generated on the app.
time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
description: This will be based on subjective data from daily questionnaires sent out to participants.
The questionnaire has yes/no questions and a likert scale (from 0-10) that participants fill in to indicate how representative each nights sleep hypnogram is. For e.g. if the participant was awake between 12am-1am but the app reports that the subject is in deep sleep, this will be captured in the questionnaire.
measure: Compare the Drive app sleep data to data from the reference devices.
time frame: 12 months (includes Phase 1 and Phase 2 and interim data analysis)
description: Analyses will be performed to compare the Drive app data with the non contact motion sensor and CPAP device.
Metrics including accuracy, correlation, total cohens kappa will be used for each signal recorded by the app which will be used to compare to the data from the reference devices.
arm group label: CPAP users
arm group type: Experimental
description: The Drive app will be used by CPAP users to identify any major issues with the usability and functionality of the app when used with CPAP therapy.
intervention type: Other
intervention name: Drive app
description: The Drive app will be used to monitor sleep metrics for users of CPAP therapy.
arm group label: CPAP users
intervention type: Device
intervention name: Non contact motion sensor
description: The non contact motion sensor will be used as a reference to the Drive app i.e. Drive app overnight recordings will be compared to the non contact motion sensor overnight recordings.
arm group label: CPAP users
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neha Banodkar
phone: (02) 8884 2656
email: neha.banodkar@resmed.com.au
facility: 
status: Recruiting
contact: 
country: Australia
responsible party type: Sponsor
mesh term: Sleep Apnea, Obstructive
sharing ipd: No