An observational study in Thyrotoxicosis and Hypothyroidism, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Seoul National University Bundang Hospital · Observational
This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.
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.
247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.
This study's planned enrollment of 120 is below the median of 148 across 104 observational studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
Exclusion Criteria:
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
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.
free T4
serum concentration of free T4
Time frame: visit 2: 1-2 weeks after enrollement (visit 1)
free T4
serum concentration of free T4
Time frame: visit 3 : 4 weeks after visit 2
free T4
serum concentration of free T4
Time frame: visit 4 : 4 weeks after visit 3
TSH
serum concentration of TSH
Time frame: visit 2: 1-2 weeks after enrollement (visit 1)
TSH
serum concentration of TSH
Time frame: visit 3 : 4 weeks after visit 2
TSH
serum concentration of TSH
Time frame: visit 4 : 4 weeks after visit 3
heart rate
continuously monitored heart rate by wearable device
Time frame: throughout the study period (average 3 months)
Activity_steps (count/min)
continuously monitored steps per minute by wearable device
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: visit 4 : 4 weeks after visit 3
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Bundang Hospital