Biosignals by Wearables in Thyroid Dysfunction

Hypothyroidism Clinical Trial

Official title:

Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806269
• Other study ID #: B-2012-654-303
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Bundang Hospital
• Contact: Jae Hoon Moon, MD
• Phone: +82-31-787-7068
• Email: jaemoon76[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypothyroidism
• Thyrotoxicosis

Intervention

Device:
• Fitbit and Glandy
Data collection from wearable devices (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) Fitbit collects user's heart rate, activity, and sleep data. Glandy collects user's subjective symptom scores.

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	free T4	serum concentration of free T4	visit 2: 1-2 weeks after enrollement (visit 1)
Primary	free T4	serum concentration of free T4	visit 3 : 4 weeks after visit 2
Primary	free T4	serum concentration of free T4	visit 4 : 4 weeks after visit 3
Primary	TSH	serum concentration of TSH	visit 2: 1-2 weeks after enrollement (visit 1)
Primary	TSH	serum concentration of TSH	visit 3 : 4 weeks after visit 2
Primary	TSH	serum concentration of TSH	visit 4 : 4 weeks after visit 3
Primary	heart rate	continuously monitored heart rate by wearable device	throughout the study period (average 3 months)
Primary	Activity_steps (count/min)	continuously monitored steps per minute by wearable device	throughout the study period (average 3 months)
Primary	Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss)	sleep start time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:15:23:00:00)	throughout the study period (average 3 months)
Primary	Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss)	sleep end time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:16:06:00:00)	throughout the study period (average 3 months)
Primary	Hyperthyroid symptom scale	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.	visit 2: 1-2 weeks after enrollement (visit 1)
Primary	Zulewski's clinical score	Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)	visit 2: 1-2 weeks after enrollement (visit 1)
Primary	Hyperthyroid symptom scale	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.	visit 3 : 4 weeks after visit 2
Primary	Zulewski's clinical score	Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)	visit 3 : 4 weeks after visit 2
Primary	Hyperthyroid symptom scale	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.	visit 4 : 4 weeks after visit 3
Primary	Zulewski's clinical score	Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)	visit 4 : 4 weeks after visit 3