Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

NCT03009357 | Completed

• 1 other identifier: B-1609/363-004
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyrotoxicosis; Graves Disease; Thyroiditis

Keywords

wearable activity tracker; thyrotoxicosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between user-generated dietary parameters on mobile applications and the thyrotoxic status

  continuous monitoring through the study period (average 3 months)

Study Arms (2)

thyrotoxicosis

patients with newly detected or recurrent thyrotoxicosis

control

euthyroid, healthy adults

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adults (20 to 60 years) undergoing newly developed or recurrent thyrotoxicosis who can use wearable activity trackers and smartphone applications

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Related Publications (2)

• Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Monitoring Resting Heart Rate Using a Wearable Activity Tracker in Patients With Thyrotoxicosis: Prospective Longitudinal Observational Study. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e159. doi: 10.2196/mhealth.9884.

  PMID: 30006328 DERIVED

• Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study. JMIR Res Protoc. 2018 Feb 21;7(2):e49. doi: 10.2196/resprot.8119.

  PMID: 29467121 DERIVED

MeSH Terms

Conditions

Thyrotoxicosis; Graves Disease; Thyroiditis

Condition Hierarchy (Ancestors)

Hyperthyroidism; Thyroid Diseases; Endocrine System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jae Hoon Moon, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 4, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)