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CompletedNCT03009357AT-thyroUpdated Apr 18, 2018

Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis

An observational study in Thyrotoxicosis, Graves Disease and Thyroiditis, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyrotoxicosis
  • Graves Disease
  • Thyroiditis

Keywords

  • wearable activity tracker
  • thyrotoxicosis
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • thyrotoxicosis

    patients with newly detected or recurrent thyrotoxicosis

  • control

    euthyroid, healthy adults

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What researchers measure

Primary outcomes

  1. Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status

    Time frame: 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

    Time frame: continuous monitoring through the study period (average 3 months)

06

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
07

References and documents

Publications

  • 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. PubMed 30006328 ↗
  • 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. PubMed 29467121 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03009357
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Jae Hoon Moon (Assistant professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jan 4, 2017
Start date
Nov 2016
Primary completion
Jun 2017
Completion
Aug 2017
Last update
Apr 18, 2018

Study contacts

Jae Hoon Moon, MD
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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