Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

Completed

• Conditions: Graves Disease; Thyroiditis; Thyrotoxicosis

• Registration Number: NCT03009357
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

The study is a single-center prospective cohort study of clinical application of continuously monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose of the study is to evaluate the association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status along with the treatment.

Detailed Description

Activity trackers to be used: Fitbit Charge HR (TM)

Data which ware provided by Fitbit app (TM) will be analyzed in this study.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients undergoing newly developed or recurrent thyrotoxicosis who are treated and followed-up in Seoul National University Bundang Hospital
• Patients who can use wearable activity trackers and smartphone applications
• In case of Graves' disease, patients who will treated by anti-thyroid drugs

Exclusion Criteria

• Patients who have thyrotoxic periodic paralysis
• In case of Graves' disease, patients who will treated by radioactive iodine therapy or thyroidectomy
• Patients who have thyrotoxicosis due to toxic nodular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status	continuous monitoring through the study period (average 3 months)

Secondary Outcome Measures

Name	Time	Method
Association between user-generated dietary parameters on mobile applications and the thyrotoxic status	continuous monitoring through the study period (average 3 months)

Trial Locations

Locations (1)

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