Trials / Completed
CompletedNCT04332770
Biosignals by Wearable Devices in Hypothyroidism
Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (actual)
- Sponsor
- Seoul National University Bundang Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2019-06-14
- Primary completion
- 2020-10-15
- Completion
- 2020-10-15
- First posted
- 2020-04-03
- Last updated
- 2021-01-05
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04332770. Inclusion in this directory is not an endorsement.