Clinical trial NCT04806269: Biosignals by Wearables in Thyroid Dysfunction
Official title: Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyrotoxicosis
Hypothyroidism
Keywords: Wearable device
Biosignals
Thyrotoxicosis
Hypothyroidism
Mobile app
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment

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.

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)

Primary outcomes:
measure: free T4
timeFrame: visit 2: 1-2 weeks after enrollement (visit 1)
measure: free T4
timeFrame: visit 3 : 4 weeks after visit 2
measure: free T4
timeFrame: visit 4 : 4 weeks after visit 3
measure: TSH
timeFrame: visit 2: 1-2 weeks after enrollement (visit 1)
measure: TSH
timeFrame: visit 3 : 4 weeks after visit 2
measure: TSH
timeFrame: visit 4 : 4 weeks after visit 3
measure: heart rate
timeFrame: throughout the study period (average 3 months)
measure: Activity_steps (count/min)
timeFrame: throughout the study period (average 3 months)
measure: Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss)
timeFrame: throughout the study period (average 3 months)
measure: Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss)
timeFrame: throughout the study period (average 3 months)
measure: Hyperthyroid symptom scale
timeFrame: visit 2: 1-2 weeks after enrollement (visit 1)
measure: Zulewski's clinical score
timeFrame: visit 2: 1-2 weeks after enrollement (visit 1)
measure: Hyperthyroid symptom scale
timeFrame: visit 3 : 4 weeks after visit 2
measure: Zulewski's clinical score
timeFrame: visit 3 : 4 weeks after visit 2
measure: Hyperthyroid symptom scale
timeFrame: visit 4 : 4 weeks after visit 3
measure: Zulewski's clinical score
timeFrame: visit 4 : 4 weeks after visit 3
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: