Biosignals by Wearable Devices in Hypothyroidism

Completed

• Conditions: Hypothyroidism
• Interventions: Other: levothyroxine withdrawal

• Registration Number: NCT04332770
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2019-06-14
• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypothyroid group	levothyroxine withdrawal	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of