Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

Graves Disease Clinical Trial

— AT-thyro  

Official title:

Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Calorie Intake by Wearable Activity Trackers in the Patients With Thyrotoxicosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009357
• Other study ID #: B-1609/363-004
• Status: Completed
• First received: December 29, 2016
• Last updated: April 16, 2018
• Start date: November 2016
• Est. completion date: August 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease
• Thyroiditis
• Thyrotoxicosis

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