Clinical trial NCT04332770: Biosignals by Wearable Devices in Hypothyroidism
Official title: Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get radioactive iodine therapy

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: physical activity (steps)
timeFrame: throughout the study period average 4 months
measure: heart rate (beats)
timeFrame: throughout the study period average 4 months
measure: free T4 level (ng/dL)
timeFrame: baseline (visit 1)
measure: free T4 level (ng/dL)
timeFrame: after 2 to 3 months (visit 2)
measure: free T4 level (ng/dL)
timeFrame: after 3 to 4 months (visit 3)
measure: Zulewski hypothyroidism score ( point)
timeFrame: baseline (visit 1)
measure: Zulewski hypothyroidism score ( point)
timeFrame: after 2 to 3 months (visit 2),
measure: Zulewski hypothyroidism score ( point)
timeFrame: after 3 to 4 months (visit 3)
measure: TSH level (mIU/L)
timeFrame: baseline (visit 1)
measure: TSH level (mIU/L)
timeFrame: after 2 to 3 months (visit 2)
measure: TSH level (mIU/L)
timeFrame: after 3 to 4 months (visit 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Hoon Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: