What is this study trying to find out about thyroid hormone replacement after total thyroidectomy?

This study aims to see if nighttime heart rate and rhythm data from a smart wristband can detect if levothyroxine doses are too low or too high before routine thyroid tests. It compares wearable data with standard thyroid hormone levels to explore earlier signs of inadequate treatment. The research is sponsored by Yeditepe University Hospital.

Who may be eligible for this total thyroidectomy clinical trial?

Adults 18 years or older who have had total thyroidectomy and started levothyroxine therapy may be eligible. Participants must be able to wear the smart wristband and attend a routine 1-month follow-up visit. People with cardiac arrhythmia, certain heart conditions, or sleep disorders may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this total thyroidectomy clinical trial?

Study-related care, including use of the smart wristband and all trial visits, is provided at no cost. Personal travel or other expenses are not guaranteed to be covered and may vary. Participants should consider these factors when joining.

Actively Recruiting

Age: 18Years +

All Genders

ID07733375

Study Evaluating Levothyroxine Dose Adjustment After Total Thyroidectomy Using Nighttime Heart Rate and Rhythm Data from a Smart Wristband Compared to Standard Thyroid Tests

Led by Yeditepe University Hospital · Updated on 2026-07-29

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

This observational study focuses on adults who have undergone total thyroidectomy and are prescribed levothyroxine replacement therapy. The research aims to determine if nighttime heart rate and heart rhythm data, collected by a smart wristband, can detect whether levothyroxine doses are too low or too high before the routine thyroid function tests performed about one month after surgery. This study evaluates how well wearable device measurements agree with standard thyroid hormone tests. Participants will wear the Xiaomi Smart Band 10 continuously during the first month after surgery. The wristband passively records nighttime heart rate and rhythm without affecting usual care. Participants will continue levothyroxine therapy as prescribed and undergo routine thyroid hormone testing, including serum thyroid-stimulating hormone TSH and free thyroxine fT4, approximately one month postoperatively. Researchers will compare wristband data to these test results to see if wearable measurements can identify under- or over-replacement earlier than standard testing. During the study, participants will wear the device and attend a routine follow-up visit for thyroid function testing about one month after surgery. Researchers will analyze the wristbands diagnostic performance, correlation with thyroid hormone levels, and its ability to predict the need for levothyroxine dose adjustments. There are no changes to the participants usual care, and no experimental treatments are given. The total participation time covers the early postoperative period up to the one-month follow-up.

CONDITIONS

Brief Title

Evaluation of Levothyroxine Replacement Therapy After Total Thyroidectomy Using a Smart Wristband

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Undergoing total thyroidectomy at Yeditepe University Faculty of Medicine Hospital
Starting levothyroxine as part of routine postoperative care
Willing and able to attend the 1-month postoperative thyroid function test follow-up
Willing and able to wear the Xiaomi Smart Band 10 during the study
Able to provide written informed consent

You will not qualify if you...

History of cardiac arrhythmia
Current use of beta-blockers or other antiarrhythmic medications
History of heart failure or advanced cardiovascular disease
Diagnosed sleep disorders that interfere with nighttime heart rate measurements
Pregnancy
Unable or unwilling to wear the smart wristband as required
Missing clinical or laboratory data needed for outcome assessment
Refusal to participate or withdrawal of consent

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring Period

Duration - 1 month

Participants wear the smart wristband continuously during the first postoperative month to record nighttime heart rate and rhythm while continuing levothyroxine therapy as prescribed. Routine thyroid function testing is performed about 1 month after surgery as part of standard care.

1 routine follow-up visit at 1 month