Biosignals by Wearables in Thyroid Dysfunction

Study Overview
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Brief Summary
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This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.

Detailed Description
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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.

Official Title
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Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction

Conditions
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Thyrotoxicosis, Hypothyroidism

Intervention / Treatment
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* Device: Fitbit and Glandy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thyroid dysfunction group<br>Subjects with thyroid dysfunction including thyrotoxicosis and hypothyroidism Subjects who were newly diagnosed or undergoing treatment for thyroid dysfunction can be included in the study. Subjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period. | Device: Fitbit and Glandy<br>* Data collection from wearable devices (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) Fitbit collects user's heart rate, activity, and sleep data. Glandy collects user's subjective symptom scores.<br>|
| Control group<br>Subjects without thyroid dysfunction including thyrotoxicosis and hypothyroidism. Subjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period. | Device: Fitbit and Glandy<br>* Data collection from wearable devices (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) Fitbit collects user's heart rate, activity, and sleep data. Glandy collects user's subjective symptom scores.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free T4 | serum concentration of free T4 | visit 2: 1-2 weeks after enrollement (visit 1) | 
| free T4 | serum concentration of free T4 | visit 3 : 4 weeks after visit 2 | 
| free T4 | serum concentration of free T4 | visit 4 : 4 weeks after visit 3 | 
| TSH | serum concentration of TSH | visit 2: 1-2 weeks after enrollement (visit 1) | 
| TSH | serum concentration of TSH | visit 3 : 4 weeks after visit 2 | 
| TSH | serum concentration of TSH | visit 4 : 4 weeks after visit 3 | 
| heart rate | continuously monitored heart rate by wearable device | throughout the study period (average 3 months) | 
| Activity_steps (count/min) | continuously monitored steps per minute by wearable device | throughout the study period (average 3 months) | 
| Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss) | sleep start time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:15:23:00:00) | throughout the study period (average 3 months) | 
| Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss) | sleep end time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:16:06:00:00) | throughout the study period (average 3 months) | 
| Hyperthyroid symptom scale | 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. | visit 2: 1-2 weeks after enrollement (visit 1) | 
| Zulewski's clinical score | Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe) | visit 2: 1-2 weeks after enrollement (visit 1) | 
| Hyperthyroid symptom scale | 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. | visit 3 : 4 weeks after visit 2 | 
| Zulewski's clinical score | Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe) | visit 3 : 4 weeks after visit 2 | 
| Hyperthyroid symptom scale | 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. | visit 4 : 4 weeks after visit 3 | 
| Zulewski's clinical score | Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe) | visit 4 : 4 weeks after visit 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable device, Biosignals, Thyrotoxicosis, Hypothyroidism, Mobile app