Biosignals by Wearable Devices in Hypothyroidism (Hypo_AT)

Seoul National University

Status: Completed

Conditions: Hypothyroidism

Treatments: Other: levothyroxine withdrawal

Study type: Observational

Funder types: Other

Identifiers

NCT04332770

B-1906/547-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 2 patient groups

Hypothyroid group

Description:

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

Treatment:

Other: levothyroxine withdrawal

Control group

Description:

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