Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hypothyroidism
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- free T4 level (ng/dL)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Jae Hoon Moon
Associate Professor
Seoul National University Bundang Hospital
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
Outcomes
Primary Outcomes
free T4 level (ng/dL)
Time Frame: after 3 to 4 months (visit 3)
thyroid hormone level
heart rate (beats)
Time Frame: throughout the study period average 4 months
heart rate data measured by wearable device, collected and recorded in 1 min increment
physical activity (steps)
Time Frame: throughout the study period average 4 months
steps data measured by wearable device, collected and recorded in 1 min increment
Zulewski hypothyroidism score ( point)
Time Frame: after 3 to 4 months (visit 3)
Scoring system to evaluate hypothyroid symptoms and signs
TSH level (mIU/L)
Time Frame: after 3 to 4 months (visit 3)
thyroid stimulating hormone level