Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hyperthyroid symptom scale
研究概览
简要总结
This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.
详细描述
An algorithm to predict thyroid dysfunction using heart rate and activity data from wearables was generated based on our previous clinical studies. This study was conducted to collect more data to advance the algorithm.
Patients with thyroid dysfunction including hypothyroidism and thyrotoxicosis were eligible for this study. During the study period, each subject wears a smart band (Fitbit Inspire 2 TM) and gets 3 times of thyroid function tests with 1-month interval. Study participants will use a mobile app (Glandy TM) to collect the symptom scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
- •Subjects who are able to use wearable devices, smart phones, and mobile apps
排除标准
- •Subjects with restrictions on normal activities due to diseases other than thyroid dysfunction
- •Subjects who are taking medications affecting heart rate
- •Subjects with diseases affecting heart rate (i.e. arrhythmia)
结局指标
主要结局
Hyperthyroid symptom scale
时间窗: visit 4 : 4 weeks after visit 3
HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function.
heart rate
时间窗: throughout the study period (average 3 months)
continuously monitored heart rate by wearable device
Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss)
时间窗: throughout the study period (average 3 months)
sleep start time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:15:23:00:00)
free T4
时间窗: visit 4 : 4 weeks after visit 3
serum concentration of free T4
Activity_steps (count/min)
时间窗: throughout the study period (average 3 months)
continuously monitored steps per minute by wearable device
Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss)
时间窗: throughout the study period (average 3 months)
sleep end time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:16:06:00:00)
TSH
时间窗: visit 4 : 4 weeks after visit 3
serum concentration of TSH
Zulewski's clinical score
时间窗: visit 4 : 4 weeks after visit 3
Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)
次要结局
未报告次要终点
研究者
Jae Hoon Moon
SeoulNUBH
Seoul National University Bundang Hospital