<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/NCT02255526</url>
  </required_header>
  <id_info>
    <org_study_id>14-004034</org_study_id>
    <nct_id>NCT02255526</nct_id>
  </id_info>
  <brief_title>BodyGuardian Respiration and Activity Validation Testing</brief_title>
  <official_title>BodyGuardian Respiration and Activity Validation Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Preventice</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Preventice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will compare BodyGuardian (BG) device measurements of breathing and activity&#xD;
      levels to the gold standard measurement techniques of gas exchange using a mouthpiece&#xD;
      connected to flow and gas analyzers measures for breathing and metabolic rate (indirect&#xD;
      calorimetry) for activity, We are hopeful these comparisons will help us improve upon the&#xD;
      measurements being made in the current version of the BG device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BodyGuardian remote monitoring system is an FDA 510 cleared device used to perform remote&#xD;
      monitoring of cardiac patients. BodyGuardian (BG) is a novel remote care platform. It&#xD;
      incorporates an adhesive strip sensor with in-built electrodes attached to a rechargeable&#xD;
      module that can determine an ECG signal and bio impedance. The module also has a 3-way&#xD;
      accelerometer. ECG, physical activity and respiration can be assessed using these sensors.&#xD;
      Although ECG data is reliable, there are doubts regarding the clinical meaning and validity&#xD;
      of the activity and respiration data.&#xD;
&#xD;
      The BG reports respiration rate and activity level (on a scale of 0 to 100). This data is&#xD;
      being used as input into other clinical algorithms including onboard ECG arrhythmia detection&#xD;
      as well as clinical care algorithms for heart failure decompensation prediction.&#xD;
&#xD;
      Respiration data is not uniformly reported and there is still doubt regarding its validity.&#xD;
      BG breathing measurements will be compared to gold standard measurement techniques of gas&#xD;
      exchange using a mouthpiece connected to flow and gas analyzer. Activity data is reported but&#xD;
      the investigators do not know how the value translates into clinically used objective&#xD;
      parameters of activity e.g. METS. BG activity measurements will be compared to the gold&#xD;
      standard activity measurements using metabolic rate (indirect calorimetry)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of successful breathing and activity measurements recorded by BG</measure>
    <time_frame>1 year</time_frame>
    <description>Measurements of BG breathing (rate and patterns) with impedance and accelerometry compared to gold standards using a mouthpiece connected to flow and gas exchange analyzers.&#xD;
BG activity level measurements based on accelerometry compared to gold standard measures of metabolic rate (indirect calorimetry).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Healthy volunteers between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart Failure</arm_group_label>
    <description>Heart failure patients between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BodyGuardian</intervention_name>
    <description>BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Heart Failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers and Heart Failure patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Volunteers between the ages of 18-80&#xD;
&#xD;
          -  Heart Failure Patients/ Volunteers between the ages of 18-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy - Non Ambulatory. With Pacemaker. Not able to sign consent.&#xD;
&#xD;
          -  Hospitalized in last 6 months for fractures, myocardial infarcts, cancer related&#xD;
             surgery, chemo therapy. Allergies to silicone or acrylic hydrogel adhesives, fragile&#xD;
             skin, and/or pregnancy&#xD;
&#xD;
          -  Heart Failure - Non Ambulatory. With Pacemaker. Not able to sign consent.&#xD;
&#xD;
          -  Hospitalized in last 6 months for fractures, cancer related surgery, chemo therapy.&#xD;
&#xD;
          -  Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Johnson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic, Rochester, MN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not an applicable study under section 801</ipd_description>
  </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/NCT02255526
org study id: 14-004034
nct id: NCT02255526
lead sponsor: 
collaborator: 
has dmc: No
This project will compare BodyGuardian (BG) device measurements of breathing and activity
      levels to the gold standard measurement techniques of gas exchange using a mouthpiece
      connected to flow and gas analyzers measures for breathing and metabolic rate (indirect
      calorimetry) for activity, We are hopeful these comparisons will help us improve upon the
      measurements being made in the current version of the BG device.
BodyGuardian remote monitoring system is an FDA 510 cleared device used to perform remote
      monitoring of cardiac patients. BodyGuardian (BG) is a novel remote care platform. It
      incorporates an adhesive strip sensor with in-built electrodes attached to a rechargeable
      module that can determine an ECG signal and bio impedance. The module also has a 3-way
      accelerometer. ECG, physical activity and respiration can be assessed using these sensors.
      Although ECG data is reliable, there are doubts regarding the clinical meaning and validity
      of the activity and respiration data.

      The BG reports respiration rate and activity level (on a scale of 0 to 100). This data is
      being used as input into other clinical algorithms including onboard ECG arrhythmia detection
      as well as clinical care algorithms for heart failure decompensation prediction.

      Respiration data is not uniformly reported and there is still doubt regarding its validity.
      BG breathing measurements will be compared to gold standard measurement techniques of gas
      exchange using a mouthpiece connected to flow and gas analyzer. Activity data is reported but
      the investigators do not know how the value translates into clinically used objective
      parameters of activity e.g. METS. BG activity measurements will be compared to the gold
      standard activity measurements using metabolic rate (indirect calorimetry)
observational model: Cohort
time perspective: Prospective
measure: Number of successful breathing and activity measurements recorded by BG
time frame: 1 year
description: Measurements of BG breathing (rate and patterns) with impedance and accelerometry compared to gold standards using a mouthpiece connected to flow and gas exchange analyzers.
BG activity level measurements based on accelerometry compared to gold standard measures of metabolic rate (indirect calorimetry).
arm group label: Healthy Volunteers
description: Healthy volunteers between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.
arm group label: Heart Failure
description: Heart failure patients between the ages of 18 and 80 will wear BodyGuardian remote monitoring system to help validate respiration and activity levels.
intervention type: Device
intervention name: BodyGuardian
description: BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG
arm group label: Healthy Volunteers
arm group label: Heart Failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Johnson, Ph.D.
role: Principal Investigator
affiliation: Mayo Clinic, Rochester, MN
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: Not an applicable study under section 801