xml: <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/NCT06026761</url>
    </required_header>
    <id_info>
      <org_study_id>Myant/Waterloo/44441</org_study_id>
      <nct_id>NCT06026761</nct_id>
    </id_info>
    <brief_title>Validation of Smart Garments for Metabolic Rate Estimation</brief_title>
    <official_title>Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Myant Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Waterloo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Myant 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to assess the use of Myant Skiin garments for the&#xD;
        purpose of estimating metabolic rate in 20 adult (18-64 yrs) healthy participants. The main&#xD;
        question it aims to answer is What is the accuracy of metabolic rate estimate from the Skiin&#xD;
        algorithm utilizing Skiin data, as compared to observation and a gold-standard sensor?&#xD;
  &#xD;
        Participants will be asked to perform a number of scripted tasks and their data will be&#xD;
        assessed and compared against gold standard wearable indirect calorimetry device (COSMED K5)&#xD;
        measurements.&#xD;
  &#xD;
        .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Following consent, the participants will first be asked to fill out a participant&#xD;
             information questionnaire.&#xD;
  &#xD;
          2. Equipment setup - SKIIN: For the SKIIN garments, participants will use the elastic&#xD;
             research belt for the study. The belt is an fabric, elastic strap that has been washed&#xD;
             and sanitized to be worn over the skin at the chest or waist. A private area for&#xD;
             changing will be provided. The SKIIN sensor pod will be attached to the holster on the&#xD;
             belt to collect inertial measurement unit (IMU) data and electrocardiography (ECG) data&#xD;
             similar to the motion and cardiac sensors in many wrist-worn activity tracking systems&#xD;
             (e.g., Apple Watch). The electrodes must be in contact with the skin to acquire ECG&#xD;
             data. Data from the Skiin garments will be acquired using the custom research interface&#xD;
             provided by the supplier. The data is acquired wirelessly and stored on the local&#xD;
             computer (and no data is sent to the cloud).&#xD;
  &#xD;
          3. Equipment setup - K5 COSMED: For the reference/criterion- standard metabolic measurement&#xD;
             system, a wearable indirect calorimetry system will be used. This system comprises of a&#xD;
             mask fitted over the mouth and nose connected to a portable device that analyzes breath&#xD;
             gas composition and volume. The mask has been cleaned and sanitized prior to use with a&#xD;
             participant. The data is acquired on the device and stored on a local computer (no data&#xD;
             is sent to the cloud).&#xD;
  &#xD;
          4. Once the equipment has been set up for the participant, an overview of the activities&#xD;
             and exercise tasks to be conducted during the protocol will be demonstrated.&#xD;
  &#xD;
          5. Exercise tasks are described in more detail in the attached document. In general, all&#xD;
             exercises can be modified by the participant to modulate intensity&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 28, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Heart rate</measure>
      <time_frame>Through study completion (1 hour total), average heart rate calculated every 1 minute</time_frame>
      <description>Heart rate obtained via ECG from the Skiin device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Metabolic rate</measure>
      <time_frame>Through study completion (1 hour total), average metabolic rate calculated every 1 minute</time_frame>
      <description>Metabolic rate obtained via the gold standard portable metabolic cart (COSMED K5)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceleration /Activity counts</measure>
      <time_frame>Through study completion (1 hour total), average activity calculated every 1 minute</time_frame>
      <description>Epoch-based physical activity counts using accelerometer data obtained through Skiin device</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>During participant inclusion</time_frame>
      <description>Participant age</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sex</measure>
      <time_frame>During participant inclusion</time_frame>
      <description>Participant sex (male, female, other)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>During participant inclusion</time_frame>
      <description>Participant weight (kg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>During participant inclusion</time_frame>
      <description>Participant height (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fitness Level</measure>
      <time_frame>During participant inclusion</time_frame>
      <description>Participant self-reported fitness level (sedentary, low, moderate, high, very high)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Healthy individuals</arm_group_label>
      <description>Metabolic study protocol</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Skiin garment and pods</intervention_name>
      <description>Participants will be asked to wear two pieces of equipment to record physiological data:&#xD;
  A Skiin garment that contains IMU and ECG sensors&#xD;
  A Cosmed K5 metabolic cart that will record breathing rate data&#xD;
  Participants will then be asked to perform various tasks of daily living (e.g. watching TV, sweeping the floor), general strength exercises (e.g. squats, triceps dips, lunges), and aerobic exercises (e.g. walking, running) as instructed by researchers</description>
      <arm_group_label>Healthy individuals</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          20 (18-64 yrs) healthy participants will be recruited as a convenience sample to validate&#xD;
          the proposed methods. An n=20 was chosen to permit a breadth of personal characteristics&#xD;
          regarding gait patterns and balance control behaviour.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Healthy male and female adult volunteers (18y - 64y old)&#xD;
  &#xD;
          must answer No to the following:&#xD;
  &#xD;
            -  Have you had musculoskeletal and/or neurological foot, ankle, knee, or hip conditions,&#xD;
               such as stroke, arthritis, trauma, joint surgery?&#xD;
  &#xD;
            -  Have you been diagnosed with a neurological disorder or cognitive impairment such as&#xD;
               Alzheimer's disease, migraine, epilepsy, dementia, Parkinson's disease, brain tumors,&#xD;
               multiple sclerosis?&#xD;
  &#xD;
            -  Have you experienced a diagnosed concussion or brain trauma in the past 6 months?&#xD;
  &#xD;
            -  Do you have a condition that limits your capacity for aerobic exercise (e.g., asthma,&#xD;
               cardiac condition)?&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  individuals with (self-reported) lower limb conditions, neurological disorders,&#xD;
               history of concussion/brain trauma, and/or condition limiting exercise is to mitigate&#xD;
               additional risk for injury and/or adverse reactions associated with exercise&#xD;
               activities.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>James Tung, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Waterloo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>James Tung, PhD</last_name>
      <phone>5198200619</phone>
      <email>james.tung@uwaterloo.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bastien Moineau, PhD</last_name>
      <phone>4166054570</phone>
      <email>bastien.moineau@myant.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Waterloo - Engineering 7</name>
        <address>
          <city>Waterloo</city>
          <state>Ontario</state>
          <zip>N2L 3G1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>James Tung, PhD</last_name>
        <phone>5198200619</phone>
        <email>james.tung@uwaterloo.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>wearable</keyword>
    <keyword>metabolic</keyword>
    <keyword>MET minute</keyword>
    <keyword>calories</keyword>
    <keyword>physical activity</keyword>
    <keyword>accelerometer</keyword>
    <keyword>heart rate</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Follow data use agreement policy as outlined by Myant (de-identified data only)</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026761
  org study id: Myant/Waterloo/44441
  nct id: NCT06026761
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this observational study is to assess the use of Myant Skiin garments for the
        purpose of estimating metabolic rate in 20 adult (18-64 yrs) healthy participants. The main
        question it aims to answer is What is the accuracy of metabolic rate estimate from the Skiin
        algorithm utilizing Skiin data, as compared to observation and a gold-standard sensor?
  
        Participants will be asked to perform a number of scripted tasks and their data will be
        assessed and compared against gold standard wearable indirect calorimetry device (COSMED K5)
        measurements.
  
        .
  1. Following consent, the participants will first be asked to fill out a participant
             information questionnaire.
  
          2. Equipment setup - SKIIN: For the SKIIN garments, participants will use the elastic
             research belt for the study. The belt is an fabric, elastic strap that has been washed
             and sanitized to be worn over the skin at the chest or waist. A private area for
             changing will be provided. The SKIIN sensor pod will be attached to the holster on the
             belt to collect inertial measurement unit (IMU) data and electrocardiography (ECG) data
             similar to the motion and cardiac sensors in many wrist-worn activity tracking systems
             (e.g., Apple Watch). The electrodes must be in contact with the skin to acquire ECG
             data. Data from the Skiin garments will be acquired using the custom research interface
             provided by the supplier. The data is acquired wirelessly and stored on the local
             computer (and no data is sent to the cloud).
  
          3. Equipment setup - K5 COSMED: For the reference/criterion- standard metabolic measurement
             system, a wearable indirect calorimetry system will be used. This system comprises of a
             mask fitted over the mouth and nose connected to a portable device that analyzes breath
             gas composition and volume. The mask has been cleaned and sanitized prior to use with a
             participant. The data is acquired on the device and stored on a local computer (no data
             is sent to the cloud).
  
          4. Once the equipment has been set up for the participant, an overview of the activities
             and exercise tasks to be conducted during the protocol will be demonstrated.
  
          5. Exercise tasks are described in more detail in the attached document. In general, all
             exercises can be modified by the participant to modulate intensity
  observational model: Cohort
  time perspective: Prospective
  measure: Heart rate
  time frame: Through study completion (1 hour total), average heart rate calculated every 1 minute
  description: Heart rate obtained via ECG from the Skiin device
  measure: Metabolic rate
  time frame: Through study completion (1 hour total), average metabolic rate calculated every 1 minute
  description: Metabolic rate obtained via the gold standard portable metabolic cart (COSMED K5)
  measure: Acceleration /Activity counts
  time frame: Through study completion (1 hour total), average activity calculated every 1 minute
  description: Epoch-based physical activity counts using accelerometer data obtained through Skiin device
  measure: Age
  time frame: During participant inclusion
  description: Participant age
  measure: Sex
  time frame: During participant inclusion
  description: Participant sex (male, female, other)
  measure: Weight
  time frame: During participant inclusion
  description: Participant weight (kg)
  measure: Height
  time frame: During participant inclusion
  description: Participant height (cm)
  measure: Fitness Level
  time frame: During participant inclusion
  description: Participant self-reported fitness level (sedentary, low, moderate, high, very high)
  arm group label: Healthy individuals
  description: Metabolic study protocol
  intervention type: Device
  intervention name: Skiin garment and pods
  description: Participants will be asked to wear two pieces of equipment to record physiological data:
  A Skiin garment that contains IMU and ECG sensors
  A Cosmed K5 metabolic cart that will record breathing rate data
  Participants will then be asked to perform various tasks of daily living (e.g. watching TV, sweeping the floor), general strength exercises (e.g. squats, triceps dips, lunges), and aerobic exercises (e.g. walking, running) as instructed by researchers
  arm group label: Healthy individuals
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: James Tung, PhD
  role: Principal Investigator
  affiliation: Waterloo University
  last name: James Tung, PhD
  phone: 5198200619
  email: james.tung@uwaterloo.ca
  last name: Bastien Moineau, PhD
  phone: 4166054570
  email: bastien.moineau@myant.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  sharing ipd: Undecided
  ipd description: Follow data use agreement policy as outlined by Myant (de-identified data only)