<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/NCT03300739</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002312</org_study_id>
    <nct_id>NCT03300739</nct_id>
  </id_info>
  <brief_title>Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients</brief_title>
  <official_title>Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational pilot study focused on collecting data on clinical variables that&#xD;
      can improve the understanding of potential predictors of disease exacerbation and&#xD;
      readmissions in COPD patients. The study aim is to understand how the variability of clinical&#xD;
      parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation),&#xD;
      physical activity and quality of life is associated with the risk of exacerbation in COPD&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed&#xD;
      Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (~1/100th&#xD;
      of the strength of a mobile phone signal) to detect respiratory movements of a person while&#xD;
      asleep- without physical contact with the individual. The device is designed to measure up to&#xD;
      5 feet, so that only the person on the side of the bed nearest the device is monitored.&#xD;
      Algorithms have been developed to analyze the respiratory movement signals and extract&#xD;
      information about respiration rate, bodily movements, sleep/wake patterns and sleep&#xD;
      disordered respiration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory rate (breaths per minute)</measure>
    <time_frame>Daily, 16 weeks</time_frame>
    <description>Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (%)</measure>
    <time_frame>Daily for 16 weeks</time_frame>
    <description>Collected via pulse oximeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.</measure>
    <time_frame>Weekly for16 weeks</time_frame>
    <description>Collected via spirometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Daily for 16 weeks</time_frame>
    <description>Collected via step counts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (kg/m^2)</measure>
    <time_frame>Baseline (Day 0) and Close-out (16 weeks)</time_frame>
    <description>Weight and height will be combined to report BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Baseline (Day 0) and Close-out (16 weeks)</time_frame>
    <description>Collected via SF-12 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Monthly for 16 weeks</time_frame>
    <description>Collected via PHQ-8 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Baseline (Day 0) and Close-out (16 weeks)</time_frame>
    <description>Collected via GAD-7 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COPD symptom assessment</measure>
    <time_frame>Weekly for 16 weeks</time_frame>
    <description>Collected via CAT questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional impairment due to dyspnea</measure>
    <time_frame>Weekly for 16 weeks</time_frame>
    <description>Collected via mMRC dyspnea scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study device usability</measure>
    <time_frame>Close-out (16 week)</time_frame>
    <description>Collected via usability questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical treatment</measure>
    <time_frame>Baseline (Day 0) and Close-out (16 weeks)</time_frame>
    <description>Collected via electronic health record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization records</measure>
    <time_frame>Baseline (Day 0) and Close-out (16 weeks)</time_frame>
    <description>Collected via electronic health record</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>COPD Exacerbation</condition>
  <condition>Copd</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with COPD diagnosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically stable and ambulatory COPD (primary diagnosis) patients who have had an&#xD;
             emergency room visit or hospitalization for an acute exacerbation of COPD within the&#xD;
             past 30 days.&#xD;
&#xD;
          2. Sufficient understanding of the English language to be able to read and understand&#xD;
             study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently on admission in the hospital, on non-invasive positive airway pressure&#xD;
             ventilation&#xD;
&#xD;
          2. Visual, hearing or cognitive impairments at the discretion of their physician.&#xD;
&#xD;
          3. Currently participating in a COPD telemonitoring program.&#xD;
&#xD;
          4. No AT&amp;T cellular coverage at their primary residence&#xD;
&#xD;
          5. Any other medical or psychological condition that, in the opinion of the investigator&#xD;
             may present an unreasonable risk to the study participant as a result of his/her&#xD;
             participation in this study, may make participant's participation unreliable, or may&#xD;
             interfere with study assessments.&#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>Stephen Agboola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Partners Connected Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 27, 2020</last_update_submitted>
  <last_update_submitted_qc>September 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Joseph C. Kvedar</investigator_full_name>
    <investigator_title>Dermatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease Progression</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/NCT03300739
org study id: 2016P002312
nct id: NCT03300739
lead sponsor: 
collaborator: 
has dmc: Yes
This is an observational pilot study focused on collecting data on clinical variables that
      can improve the understanding of potential predictors of disease exacerbation and
      readmissions in COPD patients. The study aim is to understand how the variability of clinical
      parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation),
      physical activity and quality of life is associated with the risk of exacerbation in COPD
      patients.
The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed
      Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (~1/100th
      of the strength of a mobile phone signal) to detect respiratory movements of a person while
      asleep- without physical contact with the individual. The device is designed to measure up to
      5 feet, so that only the person on the side of the bed nearest the device is monitored.
      Algorithms have been developed to analyze the respiratory movement signals and extract
      information about respiration rate, bodily movements, sleep/wake patterns and sleep
      disordered respiration.
observational model: Case-Only
time perspective: Prospective
measure: Respiratory rate (breaths per minute)
time frame: Daily, 16 weeks
description: Collected by study device, Reassure Respiration Monitor. This device uses very low power radio waves to detect respiratory movements of a person while asleep.
measure: Oxygen saturation (%)
time frame: Daily for 16 weeks
description: Collected via pulse oximeter.
measure: Forced Expiratory Volume in 1 Second (FEV1). FEV1 is the volume of air forcefully exhaled in 1 second.
time frame: Weekly for16 weeks
description: Collected via spirometer
measure: Physical activity
time frame: Daily for 16 weeks
description: Collected via step counts
measure: Body Mass Index (kg/m^2)
time frame: Baseline (Day 0) and Close-out (16 weeks)
description: Weight and height will be combined to report BMI
measure: Quality of life
time frame: Baseline (Day 0) and Close-out (16 weeks)
description: Collected via SF-12 questionnaire
measure: Depression
time frame: Monthly for 16 weeks
description: Collected via PHQ-8 questionnaire
measure: Anxiety
time frame: Baseline (Day 0) and Close-out (16 weeks)
description: Collected via GAD-7 questionnaire
measure: COPD symptom assessment
time frame: Weekly for 16 weeks
description: Collected via CAT questionnaire
measure: Functional impairment due to dyspnea
time frame: Weekly for 16 weeks
description: Collected via mMRC dyspnea scale
measure: Study device usability
time frame: Close-out (16 week)
description: Collected via usability questionnaire
measure: Medical treatment
time frame: Baseline (Day 0) and Close-out (16 weeks)
description: Collected via electronic health record
measure: Hospitalization records
time frame: Baseline (Day 0) and Close-out (16 weeks)
description: Collected via electronic health record
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Agboola, MD
role: Principal Investigator
affiliation: MGH
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Joseph C. Kvedar
investigator title: Dermatologist
mesh term: Disease Progression
sharing ipd: No