Biosignals by Wearable Devices in Hypothyroidism

NCT ID: NCT04332770

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-14

Study Completion Date

2020-10-15

Brief Summary

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This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.

Detailed Description

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A prospective observational cohort study including two groups.

Hypothyroid group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Control group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period.

Association between thyroid status and bio signals will be investigated.

Conditions

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Hypothyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypothyroid group

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

levothyroxine withdrawal

Intervention Type OTHER

All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.

Control group

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

No interventions assigned to this group

Interventions

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levothyroxine withdrawal

All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with differentiated thyroid carcinoma underwent total thyroidectomy
* Patients who are planned to get radioactive iodine therapy
* Patients who are able to use wearable device and smartphones

Exclusion Criteria

* Patients who are not able to use wearable device and smartphones
* Patients who are maintaining drugs affecting heart rate
* Patients who have any other disease which can affect biosignals
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Hoon Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Hoon Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1906/547-304

Identifier Type: -

Identifier Source: org_study_id

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