<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/NCT03009357</url>
  </required_header>
  <id_info>
    <org_study_id>B-1609/363-004</org_study_id>
    <nct_id>NCT03009357</nct_id>
  </id_info>
  <brief_title>Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis</brief_title>
  <acronym>AT-thyro</acronym>
  <official_title>Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Calorie Intake by Wearable Activity Trackers in the Patients With Thyrotoxicosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a single-center prospective cohort study of clinical application of continuously&#xD;
      monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose&#xD;
      of the study is to evaluate the association between parameters of pulse rate, activity, and&#xD;
      sleep from wearable activity trackers and the thyrotoxic status along with the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Activity trackers to be used: Fitbit Charge HR (TM)&#xD;
&#xD;
      Data which ware provided by Fitbit app (TM) will be analyzed in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status</measure>
    <time_frame>continuous monitoring through the study period (average 3 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between user-generated dietary parameters on mobile applications and the thyrotoxic status</measure>
    <time_frame>continuous monitoring through the study period (average 3 months)</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Thyrotoxicosis</condition>
  <condition>Graves Disease</condition>
  <condition>Thyroiditis</condition>
  <arm_group>
    <arm_group_label>thyrotoxicosis</arm_group_label>
    <description>patients with newly detected or recurrent thyrotoxicosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>euthyroid, healthy adults</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults (20 to 60 years) undergoing newly developed or recurrent thyrotoxicosis who can use&#xD;
        wearable activity trackers and smartphone applications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing newly developed or recurrent thyrotoxicosis who are treated and&#xD;
             followed-up in Seoul National University Bundang Hospital&#xD;
&#xD;
          -  Patients who can use wearable activity trackers and smartphone applications&#xD;
&#xD;
          -  In case of Graves' disease, patients who will treated by anti-thyroid drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have thyrotoxic periodic paralysis&#xD;
&#xD;
          -  In case of Graves' disease, patients who will treated by radioactive iodine therapy or&#xD;
             thyroidectomy&#xD;
&#xD;
          -  Patients who have thyrotoxicosis due to toxic nodular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae Hoon Moon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Jae Hoon Moon</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>wearable activity tracker</keyword>
  <keyword>thyrotoxicosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graves Disease</mesh_term>
    <mesh_term>Thyroiditis</mesh_term>
    <mesh_term>Thyrotoxicosis</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/NCT03009357
org study id: B-1609/363-004
nct id: NCT03009357
lead sponsor: 
has dmc: No
The study is a single-center prospective cohort study of clinical application of continuously
      monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose
      of the study is to evaluate the association between parameters of pulse rate, activity, and
      sleep from wearable activity trackers and the thyrotoxic status along with the treatment.
Activity trackers to be used: Fitbit Charge HR (TM)

      Data which ware provided by Fitbit app (TM) will be analyzed in this study.
observational model: Cohort
time perspective: Prospective
measure: Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status
time frame: continuous monitoring through the study period (average 3 months)
measure: Association between user-generated dietary parameters on mobile applications and the thyrotoxic status
time frame: continuous monitoring through the study period (average 3 months)
arm group label: thyrotoxicosis
description: patients with newly detected or recurrent thyrotoxicosis
arm group label: control
description: euthyroid, healthy adults
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jae Hoon Moon, MD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Jae Hoon Moon
investigator title: Assistant professor
mesh term: Graves Disease
mesh term: Thyroiditis
mesh term: Thyrotoxicosis
sharing ipd: No