<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/NCT03030313</url>
  </required_header>
  <id_info>
    <org_study_id>MA-16-05-01</org_study_id>
    <nct_id>NCT03030313</nct_id>
  </id_info>
  <brief_title>Respiration Rate Monitoring in COPD Patients</brief_title>
  <official_title>Assessment of the Temporal Changes in Nightly Respiration Rate in Combination With a Daily Symptom Reporting Application for Facilitating Early Treatment of Symptoms in COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the feasibility of using remote respiration rate monitoring as a component of home&#xD;
      care, how respiration rate data may be used in combination with other data to potentially&#xD;
      improve response to symptoms, and to generate data to inform the endpoints and effect sizes&#xD;
      of future studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research question is whether monitoring of respiration rates and variability can be&#xD;
      helpful in management of COPD patients in conjunction with or separately from self-reported&#xD;
      symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's&#xD;
      self-reported symptoms) have limited sensitivity and specificity with regard to predicting&#xD;
      decompensation. Measurement of respiration parameters and the variability of the parameters&#xD;
      may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in&#xD;
      advance of decompensation (e.g. &gt;5 days prior to patient symptoms) such that it would allow&#xD;
      an opportunity for earlier intervention with medical assessment and current therapeutic&#xD;
      approaches.&#xD;
&#xD;
      The specific primary aim includes evaluation of the correlation of respiration rate&#xD;
      parameters to indicators of healthcare utilization including drug changes, office or ER&#xD;
      visits, hospitalization, or other clinical interventions. Secondary aims include evaluation&#xD;
      of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD&#xD;
      worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration&#xD;
      rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict&#xD;
      COPD worsening requiring medical intervention, and the correlation of respiration rate&#xD;
      parameters to episode duration as defined by number of days from COPD Co-PILOT Score &gt;1 to&#xD;
      resolution (COPD Co-PILOT Score &lt;1 for 7 consecutive days).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">July 26, 2017</completion_date>
  <primary_completion_date type="Actual">July 26, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of Respiration Rate to Indicators of Healthcare Utilization</measure>
    <time_frame>12 weeks</time_frame>
    <description>Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening</measure>
    <time_frame>Baseline to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of Respiration Rate to COPD Episode Duration</measure>
    <time_frame>12 weeks</time_frame>
    <description>Episode duration is defined by number of days from COPD Co-PILOT Score &gt;1 to resolution (COPD Co-PILOT Score &lt;1 for 7 consecutive days)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Respiration rate monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reassure Non-Contact Respiration Monitor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reassure Non-Contact Respiration Monitor</intervention_name>
    <description>Reassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual. Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability. This data is uploaded to a secure cloud infrastructure for storage.</description>
    <arm_group_label>Respiration rate monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females age ≥35 years old&#xD;
&#xD;
          -  Documented diagnosis of moderate to very severe COPD (GOLD Level II-IV)&#xD;
&#xD;
          -  Weight ≥35 kg&#xD;
&#xD;
          -  Currently using the COPD Co-PILOT application (at least 3 months with 70% compliance)&#xD;
&#xD;
          -  Must be able to read and understand English and consent for themselves&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently using any form of non-invasive positive airway pressure ventilation&#xD;
&#xD;
          -  Diagnosis of significant heart failure (NYHA Class III or IV)&#xD;
&#xD;
          -  Cognitive impairment (determined by physician) that will make it hard to follow&#xD;
             instructions regarding device usage&#xD;
&#xD;
          -  BMI ≥45.5&#xD;
&#xD;
          -  Residing in hospice care, Skilled Nursing Facilities or Long Term Acute Care&#xD;
             facilities&#xD;
&#xD;
          -  Currently using a wearable drug infusion pump to deliver medication&#xD;
&#xD;
          -  Planned procedures at time of enrollment that will occur within timeframe of study and&#xD;
             require hospitalization etc.&#xD;
&#xD;
          -  Declines to participate at any time.&#xD;
&#xD;
          -  In the opinion of the Investigator, may be non-compliant with study schedules or&#xD;
             procedures&#xD;
&#xD;
          -  No cellular coverage at their primary residence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerard Criner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HGE Health Care Solutions</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>November 14, 2017</last_update_submitted>
  <last_update_submitted_qc>November 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</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>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 1, 2021</submitted>
    <returned>June 22, 2021</returned>
  </pending_results>
  <!-- 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/NCT03030313
org study id: MA-16-05-01
nct id: NCT03030313
lead sponsor: 
has dmc: No
Assess the feasibility of using remote respiration rate monitoring as a component of home
      care, how respiration rate data may be used in combination with other data to potentially
      improve response to symptoms, and to generate data to inform the endpoints and effect sizes
      of future studies.
The research question is whether monitoring of respiration rates and variability can be
      helpful in management of COPD patients in conjunction with or separately from self-reported
      symptom scores using the COPD Co-PILOT application. Current techniques (such as patient's
      self-reported symptoms) have limited sensitivity and specificity with regard to predicting
      decompensation. Measurement of respiration parameters and the variability of the parameters
      may detect worsening COPD. Changes in respiration patterns may occur sufficiently far in
      advance of decompensation (e.g. >5 days prior to patient symptoms) such that it would allow
      an opportunity for earlier intervention with medical assessment and current therapeutic
      approaches.

      The specific primary aim includes evaluation of the correlation of respiration rate
      parameters to indicators of healthcare utilization including drug changes, office or ER
      visits, hospitalization, or other clinical interventions. Secondary aims include evaluation
      of (i) the sensitivity and specificity of respiration rate monitoring results to predict COPD
      worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration
      rate monitoring results in conjunction with COPD Co-PILOT scores or components to predict
      COPD worsening requiring medical intervention, and the correlation of respiration rate
      parameters to episode duration as defined by number of days from COPD Co-PILOT Score >1 to
      resolution (COPD Co-PILOT Score <1 for 7 consecutive days).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Correlation of Respiration Rate to Indicators of Healthcare Utilization
time frame: 12 weeks
description: Indicators of healthcare utilization include change in medications for COPD, number of office or ER visits, number of hospitalizations.
measure: Sensitivity and Specificity of Respiration Rate to Predict COPD Worsening
time frame: Baseline to 12 weeks
measure: Sensitivity and Specificity of Respiration Rate in Conjunction with COPD Co-PILOT Scores to Predict COPD Worsening
time frame: 12 weeks
measure: Correlation of Respiration Rate to COPD Episode Duration
time frame: 12 weeks
description: Episode duration is defined by number of days from COPD Co-PILOT Score >1 to resolution (COPD Co-PILOT Score <1 for 7 consecutive days)
arm group label: Respiration rate monitoring
arm group type: Experimental
description: Reassure Non-Contact Respiration Monitor
intervention type: Device
intervention name: Reassure Non-Contact Respiration Monitor
description: Reassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual. Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability. This data is uploaded to a secure cloud infrastructure for storage.
arm group label: Respiration rate monitoring
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: Gerard Criner, MD
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
submitted: June 1, 2021
returned: June 22, 2021