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Biosignals by Wearables in Thyroid Dysfunction

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ClinicalTrials.gov Identifier: NCT04806269
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Jae Hoon Moon, Seoul National University Bundang Hospital

Study Description
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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
Thyrotoxicosis Hypothyroidism Device: Fitbit and Glandy

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
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. free T4 [ Time Frame: visit 2: 1-2 weeks after enrollement (visit 1) ]
    serum concentration of free T4

  2. free T4 [ Time Frame: visit 3 : 4 weeks after visit 2 ]
    serum concentration of free T4

  3. free T4 [ Time Frame: visit 4 : 4 weeks after visit 3 ]
    serum concentration of free T4

  4. TSH [ Time Frame: visit 2: 1-2 weeks after enrollement (visit 1) ]
    serum concentration of TSH

  5. TSH [ Time Frame: visit 3 : 4 weeks after visit 2 ]
    serum concentration of TSH

  6. TSH [ Time Frame: visit 4 : 4 weeks after visit 3 ]
    serum concentration of TSH

  7. heart rate [ Time Frame: throughout the study period (average 3 months) ]
    continuously monitored heart rate by wearable device

  8. Activity_steps (count/min) [ Time Frame: throughout the study period (average 3 months) ]
    continuously monitored steps per minute by wearable device

  9. 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)

  10. 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)

  11. 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.

  12. 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)

  13. 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.

  14. 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)

  15. 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.

  16. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment
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)
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806269


Contacts
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Contact: Jae Hoon Moon, MD +82-31-787-7068 jaemoon76@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Jae Hoon Moon, MD    +82-31-787-7068    jaemoon76@gmail.com   
Sub-Investigator: Chang Ho Ahn, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
More Information
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Responsible Party: Jae Hoon Moon, SeoulNUBH, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT04806269    
Other Study ID Numbers: B-2012-654-303
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jae Hoon Moon, Seoul National University Bundang Hospital:
Wearable device
Biosignals
Thyrotoxicosis
Hypothyroidism
Mobile app
Additional relevant MeSH terms:
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Hypothyroidism
Thyrotoxicosis
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism