Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- free T4 level (ng/dL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
free T4 level (ng/dL)
时间窗: after 3 to 4 months (visit 3)
thyroid hormone level
heart rate (beats)
时间窗: throughout the study period average 4 months
heart rate data measured by wearable device, collected and recorded in 1 min increment
physical activity (steps)
时间窗: throughout the study period average 4 months
steps data measured by wearable device, collected and recorded in 1 min increment
Zulewski hypothyroidism score ( point)
时间窗: after 3 to 4 months (visit 3)
Scoring system to evaluate hypothyroid symptoms and signs
TSH level (mIU/L)
时间窗: after 3 to 4 months (visit 3)
thyroid stimulating hormone level
次要结局
未报告次要终点
研究者
Jae Hoon Moon
Associate Professor
Seoul National University Bundang Hospital