Biosignals by Wearable Devices in Hypothyroidism

Hypothyroidism Clinical Trial

— Hypo_AT  

Official title:

Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332770
• Other study ID #: B-1906/547-304
• Status: Completed
• Start date: June 14, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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