Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Thyrotoxicosis
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Hyperthyroid symptom scale
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.
Detailed Description
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.
Investigators
Jae Hoon Moon
SeoulNUBH
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Hyperthyroid symptom scale
Time Frame: 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
Time Frame: throughout the study period (average 3 months)
continuously monitored heart rate by wearable device
Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss)
Time Frame: 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
Time Frame: visit 4 : 4 weeks after visit 3
serum concentration of free T4
Activity_steps (count/min)
Time Frame: 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)
Time Frame: 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
Time Frame: visit 4 : 4 weeks after visit 3
serum concentration of TSH
Zulewski's clinical score
Time Frame: visit 4 : 4 weeks after visit 3
Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)