<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/NCT04453891</url>
  </required_header>
  <id_info>
    <org_study_id>Hexoskin COVID-19 Study</org_study_id>
    <nct_id>NCT04453891</nct_id>
  </id_info>
  <brief_title>Hexoskin Feasibility Study With COVID-19 Patients</brief_title>
  <official_title>Evaluating the Feasibility of Monitoring Symptomatic COVID-19 Patients, and Predicting Disease Progression Using a Validated Digital Health Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nguyen Thu Ngan Trinh</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carré Technologies Inc.</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>
      This pilot study aims to investigate the feasibility of using Hexoskin cardiorespiratory and&#xD;
      activity data, as well as patient symptomatology, to provide an AI model for disease&#xD;
      progression that will be at the service of the clinical team to recommend the best customized&#xD;
      and evolving care trajectory for each patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following protocol proposes a mixed methods pilot study, whereby the immediate purpose is&#xD;
      to generate quantifiable information regarding the feasibility of a virtual trial with the&#xD;
      Hexoskin Platform, collection of data quality in COVID-19 patients, and values for algorithm&#xD;
      construction. In essence, sixteen participants with a confirmed COVID-19 diagnosis will be&#xD;
      invited to wear the Hexoskin biometric garment during the course of several hours per week,&#xD;
      over a period of 28 days. In addition to the biometric data collection, participants will be&#xD;
      invited to complete four questionnaires. The biometric data will be combined to the&#xD;
      sociodemographic information and patient symptomatology to construct an algorithm which can&#xD;
      accurately predict patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Internal timeline was delayed, logistics delays&#xD;
  </why_stopped>
  <start_date type="Actual">July 15, 2022</start_date>
  <completion_date type="Actual">August 9, 2022</completion_date>
  <primary_completion_date type="Actual">August 9, 2022</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>Qualitative assessment of the feasibility of the Hexoskin Platform and Virtual Recruitment Process via three subjective feedback questionnaires provided to all patients enrolled in the study.</measure>
    <time_frame>Up to six months</time_frame>
    <description>Evaluating the feasibility of a virtual trial to collect physiological data with the Hexoskin Platform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ensure the collection of high-quality data during wake and sleep activities, registered as overall &gt; 90% good quality cardiac data and overall &gt; 90% good quality respiratory data per recording.</measure>
    <time_frame>Up to six months</time_frame>
    <description>Assessing the quality of the data collected with Hexoskin with the Hexoskin quality assessment channels from patients recruited during a virtual trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ensure adequate patient compliance, qualified as &gt; 75% of total recording hours completed, and &gt; 75% of daily questionnaires completed.</measure>
    <time_frame>Up to six months</time_frame>
    <description>Determine the participant's level of compliance with study procedures of the research protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigate the predictive power of Hexoskin physiological data, patient information and symptoms information to correctly classify patient disease progression quantified as the area under the receiver operator characteristics curve (AUC ROC &gt; 0.70).</measure>
    <time_frame>Up to six months</time_frame>
    <description>Assessing the feasibility to use the data collected to build a predictive algorithm for the Hexoskin Remote Monitoring Platform.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monitoring physiological data with the Hexoskin smart shirt</intervention_name>
    <description>Participants will be monitored using a validated biometric garment (Hexoskin smart shirt). Cardiorespiratory and activity data will be collected over a 28-day monitoring period. Participants will be invited to wear the shirt during the day and at night.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COVID-19 positive patients aged 55 and above, and resident of any state in the United&#xD;
        States.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum waist size of 24 inches, and maximum waist size of 45 inches&#xD;
&#xD;
          -  Confirmed COVID-19 diagnosis from a licensed healthcare practitioner&#xD;
&#xD;
          -  Permanent resident or citizen of the United States&#xD;
&#xD;
          -  Access to a smartphone&#xD;
&#xD;
          -  Access to a functional email&#xD;
&#xD;
          -  Access to a thermometer&#xD;
&#xD;
          -  Access to a measuring tape&#xD;
&#xD;
          -  Experiencing at least three of the following COVID-19 symptoms (fever, cough,&#xD;
             difficulty breathing, intense fatigue, sudden loss of smell and/or taste without nasal&#xD;
             congestion, sore throat, headache, aching muscles, loss of appetite, diarrhea).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hexoskin should not be used by people with allergies to the following materials:&#xD;
             polyester, synthetic fibers. Usage must be stopped if the product causes skin&#xD;
             irritation or rashes.&#xD;
&#xD;
          -  Hexoskin should not be used by people with Pacemakers or Implantable&#xD;
             Cardioverter-Defibrillator (ICD) devices.&#xD;
&#xD;
          -  Hexoskin must not be used simultaneously with a Holter Monitor, as the equipment would&#xD;
             interfere with the placement of the Hexoskin sensors.&#xD;
&#xD;
          -  Hexoskin must not be used in an MRI machine as it contains metallic parts.&#xD;
&#xD;
          -  Individuals who do not fit any of the Hexoskin Shirts sizes (Men: between 2XS - 6XL,&#xD;
             Women: between 2XS - 4XL).&#xD;
&#xD;
          -  Individuals who have a documented medical condition or illness requiring intensive&#xD;
             medical treatment.&#xD;
&#xD;
          -  Women of Childbearing Potential whom are not using effective contraceptive measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nguyen Thu Ngan Trinh</last_name>
    <role>Principal Investigator</role>
    <affiliation>1-888-887-2044</affiliation>
  </overall_official>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 9, 2022</last_update_submitted>
  <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Carré Technologies Inc.</investigator_affiliation>
    <investigator_full_name>Nguyen Thu Ngan Trinh</investigator_full_name>
    <investigator_title>Clinical Applications Specialist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04453891
org study id: Hexoskin COVID-19 Study
nct id: NCT04453891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study aims to investigate the feasibility of using Hexoskin cardiorespiratory and
      activity data, as well as patient symptomatology, to provide an AI model for disease
      progression that will be at the service of the clinical team to recommend the best customized
      and evolving care trajectory for each patient.
The following protocol proposes a mixed methods pilot study, whereby the immediate purpose is
      to generate quantifiable information regarding the feasibility of a virtual trial with the
      Hexoskin Platform, collection of data quality in COVID-19 patients, and values for algorithm
      construction. In essence, sixteen participants with a confirmed COVID-19 diagnosis will be
      invited to wear the Hexoskin biometric garment during the course of several hours per week,
      over a period of 28 days. In addition to the biometric data collection, participants will be
      invited to complete four questionnaires. The biometric data will be combined to the
      sociodemographic information and patient symptomatology to construct an algorithm which can
      accurately predict patient outcomes.
observational model: Cohort
time perspective: Prospective
measure: Qualitative assessment of the feasibility of the Hexoskin Platform and Virtual Recruitment Process via three subjective feedback questionnaires provided to all patients enrolled in the study.
time frame: Up to six months
description: Evaluating the feasibility of a virtual trial to collect physiological data with the Hexoskin Platform.
measure: Ensure the collection of high-quality data during wake and sleep activities, registered as overall > 90% good quality cardiac data and overall > 90% good quality respiratory data per recording.
time frame: Up to six months
description: Assessing the quality of the data collected with Hexoskin with the Hexoskin quality assessment channels from patients recruited during a virtual trial.
measure: Ensure adequate patient compliance, qualified as > 75% of total recording hours completed, and > 75% of daily questionnaires completed.
time frame: Up to six months
description: Determine the participant's level of compliance with study procedures of the research protocol.
measure: Investigate the predictive power of Hexoskin physiological data, patient information and symptoms information to correctly classify patient disease progression quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.70).
time frame: Up to six months
description: Assessing the feasibility to use the data collected to build a predictive algorithm for the Hexoskin Remote Monitoring Platform.
intervention type: Device
intervention name: Monitoring physiological data with the Hexoskin smart shirt
description: Participants will be monitored using a validated biometric garment (Hexoskin smart shirt). Cardiorespiratory and activity data will be collected over a 28-day monitoring period. Participants will be invited to wear the shirt during the day and at night.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Nguyen Thu Ngan Trinh
role: Principal Investigator
affiliation: 1-888-887-2044
responsible party type: Sponsor-Investigator
investigator affiliation: Carré Technologies Inc.
investigator full name: Nguyen Thu Ngan Trinh
investigator title: Clinical Applications Specialist
mesh term: COVID-19
sharing ipd: No