Biosignals by Wearable Devices in Hypothyroidism

Overview

This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.

Full Title of Study: “Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2020

Detailed Description

A prospective observational cohort study including two groups.

Hypothyroid group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Control group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period.

Association between thyroid status and bio signals will be investigated.

Interventions

  • Other: levothyroxine withdrawal
    • All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.

Arms, Groups and Cohorts

  • Hypothyroid group
    • Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices
  • Control group
    • Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Clinical Trial Outcome Measures

Primary Measures

  • physical activity (steps)
    • Time Frame: throughout the study period average 4 months
    • steps data measured by wearable device, collected and recorded in 1 min increment
  • heart rate (beats)
    • Time Frame: throughout the study period average 4 months
    • heart rate data measured by wearable device, collected and recorded in 1 min increment
  • free T4 level (ng/dL)
    • Time Frame: baseline (visit 1)
    • thyroid hormone level
  • free T4 level (ng/dL)
    • Time Frame: after 2 to 3 months (visit 2)
    • thyroid hormone level
  • free T4 level (ng/dL)
    • Time Frame: after 3 to 4 months (visit 3)
    • thyroid hormone level
  • Zulewski hypothyroidism score ( point)
    • Time Frame: baseline (visit 1)
    • Scoring system to evaluate hypothyroid symptoms and signs
  • Zulewski hypothyroidism score ( point)
    • Time Frame: after 2 to 3 months (visit 2),
    • Scoring system to evaluate hypothyroid symptoms and signs
  • Zulewski hypothyroidism score ( point)
    • Time Frame: after 3 to 4 months (visit 3)
    • Scoring system to evaluate hypothyroid symptoms and signs
  • TSH level (mIU/L)
    • Time Frame: baseline (visit 1)
    • thyroid stimulating hormone level
  • TSH level (mIU/L)
    • Time Frame: after 2 to 3 months (visit 2)
    • thyroid stimulating hormone level
  • TSH level (mIU/L)
    • Time Frame: after 3 to 4 months (visit 3)
    • thyroid stimulating hormone level

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with differentiated thyroid carcinoma underwent total thyroidectomy
  • Patients who are planned to get radioactive iodine therapy
  • Patients who are able to use wearable device and smartphones

Exclusion Criteria

  • Patients who are not able to use wearable device and smartphones
  • Patients who are maintaining drugs affecting heart rate
  • Patients who have any other disease which can affect biosignals

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jae Hoon Moon, Associate Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Jae Hoon Moon, MD, Principal Investigator, Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Jae Hoon Moon, MD, +82317877068, jaemoon76@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.