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NCT Number: NCT07733375

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

The goal of this observational study is to determine whether nighttime heart rate and heart rhythm data collected by a smart wristband can identify under- or over-replacement with levothyroxine before the routine 1-month thyroid function tests in adults who have undergone total thyroidectomy.

After total thyroidectomy, patients usually start levothyroxine replacement therapy, and the dose is adjusted about 1 month later based on thyroid function tests. This study aims to determine whether changes in nighttime heart rate and heart rhythm can provide an earlier indication that the levothyroxine dose is too low or too high.

The main questions it aims to answer are:

Can nighttime heart rate and heart rhythm measured by a smart wristband identify under- or over-replacement with levothyroxine before routine thyroid function testing? How well do smart wristband measurements agree with thyroid function test results?

Participants will:

Wear a smart wristband after total thyroidectomy. Continue taking levothyroxine as prescribed by their physician. Undergo routine thyroid function testing approximately 1 month after surgery as part of standard clinical care.

Allow researchers to compare smart wristband measurements with thyroid function test results to evaluate whether wearable data can provide an earlier indication of inadequate or excessive levothyroxine replacement.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University Koşuyolu Hospital

Istanbul, Kadıköy, 34718, Turkey (Türkiye)

Location status: Recruiting

About this study

Total thyroidectomy is commonly performed for both benign and malignant thyroid diseases. Following surgery, lifelong levothyroxine replacement therapy is required to maintain euthyroidism. The initial levothyroxine dose is generally determined according to clinical characteristics such as body weight and is subsequently adjusted based on thyroid function tests, which are routinely performed approximately 4 to 6 weeks after surgery. During this period, some individuals may experience symptoms related to under-replacement or over-replacement before biochemical assessment becomes available.

Thyroid hormones have well-established effects on the cardiovascular system. Alterations in thyroid hormone levels can influence heart rate, cardiac rhythm, and autonomic nervous system activity. Recent advances in wearable technology have enabled continuous, noninvasive monitoring of physiological parameters, including nighttime heart rate and heart rhythm. These measurements may provide early physiological changes associated with inadequate thyroid hormone replacement.

The primary objective of this prospective observational study is to evaluate whether nighttime heart rate and heart rhythm data obtained from a smart wristband can identify under-replacement or over-replacement of levothyroxine before the routine postoperative thyroid function assessment. Smart wristband-derived physiological measurements will be compared with serum thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels obtained during standard postoperative follow-up.

The study will enroll adults undergoing total thyroidectomy who require postoperative levothyroxine replacement therapy. Participants will wear a smart wristband during the early postoperative period while continuing standard clinical care. No experimental intervention or modification of routine treatment will be performed. The findings may help determine whether wearable device-derived physiological data can serve as an early, noninvasive indicator of inadequate levothyroxine replacement and support more timely dose adjustment after total thyroidectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older.
  • Undergoing total thyroidectomy at the Department of General Surgery, Yeditepe University Faculty of Medicine Hospital.
  • Initiation of postoperative levothyroxine replacement therapy as part of routine clinical care.
  • Willing and able to attend the routine 1-month postoperative thyroid function test follow-up.
  • Willing and able to wear the Xiaomi Smart Band 10 throughout the study period.
  • Able to provide written informed consent.

Exclusion criteria

  • History of cardiac arrhythmia.
  • Current use of beta-blockers or other antiarrhythmic medications that may affect heart rate.
  • History of heart failure or advanced cardiovascular disease.
  • Diagnosed sleep disorders that may interfere with nighttime heart rate measurements.
  • Pregnancy.
  • Inability or unwillingness to wear the Xiaomi Smart Band 10 as required.
  • Missing clinical or laboratory data required for outcome assessment.
  • Refusal to participate or withdrawal of informed consent.

Treatment and study plan

Xiomi Smart Band 10

Device

Participants will wear a smart wristband continuously during the first postoperative month following total thyroidectomy. The device will passively record nighttime heart rate and heart rhythm data without affecting routine clinical care. The collected physiological data will be compared with thyroid function test results obtained 1 month after surgery to evaluate whether wearable-derived measurements can identify under- or over-replacement with levothyroxine before routine biochemical assessment.

Primary outcomes

  1. Diagnostic Performance of Smart Wristband-Derived Nighttime Heart Rate and Heart Rhythm for Detecting Inadequate Levothyroxine Replacement

    Time frame: 1 month after total thyroidectomy

    To evaluate the ability of nighttime heart rate and heart rhythm parameters recorded by a smart wristband during the first postoperative month to identify under- or over-replacement with levothyroxine, using thyroid function tests (TSH and free T4) obtained 1 month after total thyroidectomy as the reference standard.

Secondary outcomes

  1. Correlation Between Smart Wristband Physiological Data and Thyroid Function Tests

    Time frame: 1 month after total thyroidectomy

    To assess the correlation between nighttime heart rate and heart rhythm parameters and serum TSH and free thyroxine (fT4) levels measured 1 month after surgery.

  2. Prediction of Levothyroxine Dose Adjustment

    Time frame: 1 month after total thyroidectomy

    To evaluate whether smart wristband-derived physiological measurements can predict the need for levothyroxine dose adjustment at the first postoperative follow-up visit.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Yeditepe University Hospital

Other

Registry information

Official study title

Comparative Evaluation of the Effectiveness of Levothyroxine Replacement Therapy After Total Thyroidectomy Using Smart Wristband-Measured Nocturnal Heart Rate and Heart Rhythm Parameters Versus Thyroid Function Tests

Acronym: SMART-THY

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Sep 25, 2026

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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