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AT-thyro: Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03009357
Collaborator
(none)
40
Enrollment
1
Location
9
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Activity trackers to be used: Fitbit Charge HR (TM)

    Data which ware provided by Fitbit app (TM) will be analyzed in this study.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Nov 1, 2016
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Aug 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    thyrotoxicosis

    patients with newly detected or recurrent thyrotoxicosis
    control

    euthyroid, healthy adults

    Outcome Measures

    Primary Outcome Measures

    1. Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status [continuous monitoring through the study period (average 3 months)]

    Secondary Outcome Measures

    1. Association between user-generated dietary parameters on mobile applications and the thyrotoxic status [continuous monitoring through the study period (average 3 months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing newly developed or recurrent thyrotoxicosis who are treated and followed-up in Seoul National University Bundang Hospital

    • Patients who can use wearable activity trackers and smartphone applications

    • In case of Graves' disease, patients who will treated by anti-thyroid drugs

    Exclusion Criteria:

    • Patients who have thyrotoxic periodic paralysis

    • In case of Graves' disease, patients who will treated by radioactive iodine therapy or thyroidectomy

    • Patients who have thyrotoxicosis due to toxic nodular disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Principal Investigator: Jae Hoon Moon, MD, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jae Hoon Moon, Assistant professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT03009357
    Other Study ID Numbers:
    • B-1609/363-004
    First Posted:
    Jan 4, 2017
    Last Update Posted:
    Apr 18, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jae Hoon Moon, Assistant professor, Seoul National University Bundang Hospital
    wearable activity tracker
    thyrotoxicosis
    Additional relevant MeSH terms:
    Graves Disease
    Thyroiditis
    Thyrotoxicosis

    Study Results

    No Results Posted as of Apr 18, 2018