Hypothyroidism, Thyrotoxicosis
Conditions
Keywords
Wearable device, Biosignals, Thyrotoxicosis, Hypothyroidism, Mobile app
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.
Interventions
DEVICEFitbit 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.
Sponsors
Seoul National University Bundang Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| free T4 | visit 2: 1-2 weeks after enrollement (visit 1) | serum concentration of free T4 |
| 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) |
| TSH | visit 2: 1-2 weeks after enrollement (visit 1) | 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) |
| 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) |
Countries
South Korea
Contacts
Primary ContactJae Hoon Moon, MD
Outcome results
None listed