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NCT Number: NCT04332770

Biosignals by Wearable Devices in Hypothyroidism

This is a prospective observational cohort study. Monitoring continuous biosignals using wearable devices in thyroid cancer patients who are planned to withdraw their levothyroxine for radioactive iodine therapy. Through this, bio signals can be collected in the subjects in hypothyroid status. Physical activity, heart rate, and sleep data will be collected during the study period.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

A prospective observational cohort study including two groups.

Hypothyroid group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to withdraw their levothyroxine for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices

Control group:

Patients with differentiated thyroid carcinoma underwent total thyroidectomy Patients who are planned to get rhTSH (not to withdraw their levothyroxine) for radioactive iodine therapy Biosignals will be monitored continuously using Fitbit devices Thyroid hormone levels and continuously collected bio signals including activity, heart rate, and sleep data will be obtained during study period.

Association between thyroid status and bio signals will be investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with differentiated thyroid carcinoma underwent total thyroidectomy
  • Patients who are planned to get radioactive iodine therapy
  • Patients who are able to use wearable device and smartphones

Exclusion criteria

  • Patients who are not able to use wearable device and smartphones
  • Patients who are maintaining drugs affecting heart rate
  • Patients who have any other disease which can affect biosignals

Treatment and study plan

levothyroxine withdrawal

Other

All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.

Primary outcomes

  1. physical activity (steps)

    Time frame: throughout the study period average 4 months

    steps data measured by wearable device, collected and recorded in 1 min increment

  2. heart rate (beats)

    Time frame: throughout the study period average 4 months

    heart rate data measured by wearable device, collected and recorded in 1 min increment

  3. free T4 level (ng/dL)

    Time frame: baseline (visit 1)

    thyroid hormone level

  4. free T4 level (ng/dL)

    Time frame: after 2 to 3 months (visit 2)

    thyroid hormone level

  5. free T4 level (ng/dL)

    Time frame: after 3 to 4 months (visit 3)

    thyroid hormone level

  6. Zulewski hypothyroidism score ( point)

    Time frame: baseline (visit 1)

    Scoring system to evaluate hypothyroid symptoms and signs

  7. Zulewski hypothyroidism score ( point)

    Time frame: after 2 to 3 months (visit 2),

    Scoring system to evaluate hypothyroid symptoms and signs

  8. Zulewski hypothyroidism score ( point)

    Time frame: after 3 to 4 months (visit 3)

    Scoring system to evaluate hypothyroid symptoms and signs

  9. TSH level (mIU/L)

    Time frame: baseline (visit 1)

    thyroid stimulating hormone level

  10. TSH level (mIU/L)

    Time frame: after 2 to 3 months (visit 2)

    thyroid stimulating hormone level

  11. TSH level (mIU/L)

    Time frame: after 3 to 4 months (visit 3)

    thyroid stimulating hormone level

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Clinical Application of Continuous Monitoring Data for Biosignals by Commercially Available Wearable Devices in the Patients With Hypothyroidism

Acronym: Hypo_AT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2020
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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