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Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis (AT-thyro)

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ClinicalTrials.gov Identifier: NCT03009357
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jae Hoon Moon, 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.

Condition or disease
Thyrotoxicosis Graves Disease Thyroiditis

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Group/Cohort
thyrotoxicosis
patients with newly detected or recurrent thyrotoxicosis
control
euthyroid, healthy adults



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009357


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Jae Hoon Moon, MD Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Hoon Moon, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03009357    
Other Study ID Numbers: B-1609/363-004
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jae Hoon Moon, Seoul National University Bundang Hospital:
wearable activity tracker
thyrotoxicosis
Additional relevant MeSH terms:
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Graves Disease
Thyroiditis
Thyrotoxicosis
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases