Biosignals by Wearables in Thyroid Dysfunction

NCT04806269 | Unknown

• 1 other identifier: B-2012-654-303
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyrotoxicosis; Hypothyroidism

Keywords

Wearable device; Biosignals; Thyrotoxicosis; Hypothyroidism; Mobile app

Outcome Measures

Primary Outcomes (16)

• free T4

  serum concentration of free T4

  visit 2: 1-2 weeks after enrollement (visit 1)

• free T4

  serum concentration of free T4

  visit 3 : 4 weeks after visit 2

• free T4

  serum concentration of free T4

  visit 4 : 4 weeks after visit 3

• TSH

  serum concentration of TSH

  visit 2: 1-2 weeks after enrollement (visit 1)

• TSH

  serum concentration of TSH

  visit 3 : 4 weeks after visit 2

• TSH

  serum concentration of TSH

  visit 4 : 4 weeks after visit 3

• heart rate

  continuously monitored heart rate by wearable device

  throughout the study period (average 3 months)

• Activity_steps (count/min)

  continuously monitored steps per minute by wearable device

  throughout the study period (average 3 months)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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

• 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

Study Arms (2)

Thyroid dysfunction group

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.

Device: Fitbit and Glandy

Control group

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.

Device: Fitbit and Glandy

Interventions

Fitbit and Glandy DEVICE

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.

Control group; Thyroid dysfunction group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Thyrotoxicosis; Hypothyroidism

Condition Hierarchy (Ancestors)

Hyperthyroidism; Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Jae Hoon Moon, MD

CONTACT

+82-31-787-7068; jaemoon76@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SeoulNUBH

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: March 19, 2021
• Study Start: January 18, 2021
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

KR (1)