Biosignals by Wearables in Thyroid Dysfunction
Study Details
Study Description
Brief Summary
This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Thyroid dysfunction group 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
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.
|
| Control group 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
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.
|
Outcome Measures
Primary Outcome Measures
- free T4 [visit 2: 1-2 weeks after enrollement (visit 1)]
serum concentration of free T4
- free T4 [visit 3 : 4 weeks after visit 2]
serum concentration of free T4
- free T4 [visit 4 : 4 weeks after visit 3]
serum concentration of free T4
- TSH [visit 2: 1-2 weeks after enrollement (visit 1)]
serum concentration of TSH
- TSH [visit 3 : 4 weeks after visit 2]
serum concentration of TSH
- TSH [visit 4 : 4 weeks after visit 3]
serum concentration of TSH
- heart rate [throughout the study period (average 3 months)]
continuously monitored heart rate by wearable device
- Activity_steps (count/min) [throughout the study period (average 3 months)]
continuously monitored steps per minute by wearable device
- Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss) [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)
- Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss) [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)
- Hyperthyroid symptom scale [visit 2: 1-2 weeks after enrollement (visit 1)]
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.
- Zulewski's clinical score [visit 2: 1-2 weeks after enrollement (visit 1)]
Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)
- Hyperthyroid symptom scale [visit 3 : 4 weeks after visit 2]
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.
- Zulewski's clinical score [visit 3 : 4 weeks after visit 2]
Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)
- Hyperthyroid symptom scale [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.
- Zulewski's clinical score [visit 4 : 4 weeks after visit 3]
Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)
Eligibility Criteria
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
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Subjects who are taking medications affecting heart rate
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Subjects with diseases affecting heart rate (i.e. arrhythmia)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Seoul National University Bundang Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B-2012-654-303