ThyrotoxicosisNCT04806269
Biosignals by Wearables in Thyroid Dysfunction
An observational study of Thyrotoxicosis and Hypothyroidism, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyrotoxicosis, Hypothyroidism
- What is being tested?
- Fitbit and Glandy
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Jae Hoon Moon, MD, +82-31-787-7068, jaemoon76@gmail.com
Chang Ho Ahn, MD
About this study
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
This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.
Read the 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.
- Conditions
- Thyrotoxicosis, Hypothyroidism
- Being tested
- Fitbit and Glandy
- Keywords
- Wearable device, Biosignals, Thyrotoxicosis, Hypothyroidism, Mobile app
- Medical subject headings
- Thyrotoxicosis, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit and GlandyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fitbit and Glandy | |
| 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. Receives: Device: Fitbit and Glandy |
What is being measured
The primary outcome is the main question the study is designed to answer.
free T4
serum concentration of free T4
Measured: visit 2: 1-2 weeks after enrollement (visit 1)
free T4
serum concentration of free T4
Measured: visit 3 : 4 weeks after visit 2
free T4
serum concentration of free T4
Measured: visit 4 : 4 weeks after visit 3
TSH
serum concentration of TSH
Measured: visit 2: 1-2 weeks after enrollement (visit 1)
TSH
serum concentration of TSH
Measured: visit 3 : 4 weeks after visit 2
TSH
serum concentration of TSH
Measured: visit 4 : 4 weeks after visit 3
heart rate
continuously monitored heart rate by wearable device
Measured: throughout the study period (average 3 months)
Activity_steps (count/min)
continuously monitored steps per minute by wearable device
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: visit 4 : 4 weeks after visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start18 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyrotoxicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hoon Moon, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806269
- Sponsor's protocol ID
- B-2012-654-303
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04806269
- Acronym / sponsor ID
- B-2012-654-303
- Conditions
- Thyrotoxicosis, Hypothyroidism
- Keywords
- Wearable device, Biosignals, Thyrotoxicosis, Hypothyroidism, Mobile app
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid dysfunction group | – | Device: Fitbit and GlandySubjects 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. |
| Control group | – | Device: Fitbit and GlandySubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit and GlandyData 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. | Device | Control group, Thyroid dysfunction group |
Primary outcome
free T4
Time frame: visit 2: 1-2 weeks after enrollement (visit 1)
serum concentration of free T4
free T4
Time frame: visit 3 : 4 weeks after visit 2
serum concentration of free T4
free T4
Time frame: visit 4 : 4 weeks after visit 3
serum concentration of free T4
TSH
Time frame: visit 2: 1-2 weeks after enrollement (visit 1)
serum concentration of TSH
TSH
Time frame: visit 3 : 4 weeks after visit 2
serum concentration of TSH
TSH
Time frame: visit 4 : 4 weeks after visit 3
serum concentration of TSH
heart rate
Time frame: throughout the study period (average 3 months)
continuously monitored heart rate by wearable device
Activity_steps (count/min)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: visit 4 : 4 weeks after visit 3
Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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Thyrotoxicosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyrotoxicosis and Hypothyroidism, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hoon Moon, MD (+82-31-787-7068, jaemoon76@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
free T4 (time frame: visit 2: 1-2 weeks after enrollement (visit 1)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.