Biosignals by Wearables in Thyroid Dysfunction

Recruiting

• Conditions: Thyrotoxicosis; Hypothyroidism
• Interventions: Device: Fitbit and Glandy

• Registration Number: NCT04806269
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.

Detailed Description

An algorithm to predict thyroid dysfunction using heart rate and activity data from wearables was generated based on our previous clinical studies. This study was conducted to collect more data to advance the algorithm.

Patients with thyroid dysfunction including hypothyroidism and thyrotoxicosis were eligible for this study. During the study period, each subject wears a smart band (Fitbit Inspire 2 TM) and gets 3 times of thyroid function tests with 1-month interval. Study participants will use a mobile app (Glandy TM) to collect the symptom scores.

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
• Subjects who are able to use wearable devices, smart phones, and mobile apps

Exclusion Criteria

• Subjects with restrictions on normal activities due to diseases other than thyroid dysfunction
• Subjects who are taking medications affecting heart rate
• Subjects with diseases affecting heart rate (i.e. arrhythmia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Fitbit and Glandy	Subjects without thyroid dysfunction including thyrotoxicosis and hypothyroidism. Subjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period.
Thyroid dysfunction group	Fitbit and Glandy	Subjects with thyroid dysfunction including thyrotoxicosis and hypothyroidism Subjects who were newly diagnosed or undergoing treatment for thyroid dysfunction can be included in the study. Subjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period.

Primary Outcome Measures

Name	Time	Method
Hyperthyroid symptom scale	visit 4 : 4 weeks after visit 3	HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function.
heart rate	throughout the study period (average 3 months)	continuously monitored heart rate by wearable device
Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss)	throughout the study period (average 3 months)	sleep start time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:15:23:00:00)
free T4	visit 4 : 4 weeks after visit 3	serum concentration of free T4
Activity_steps (count/min)	throughout the study period (average 3 months)	continuously monitored steps per minute by wearable device
Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss)	throughout the study period (average 3 months)	sleep end time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:16:06:00:00)
TSH	visit 4 : 4 weeks after visit 3	serum concentration of TSH
Zulewski's clinical score	visit 4 : 4 weeks after visit 3	Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)

Trial Locations

Locations (1)

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