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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Xiomi Smart Band 10
  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 assessmen

Первичные конечные точки

• Diagnostic Performance of Smart Wristband-Derived Nighttime Heart Rate and Heart Rhythm for Detecting Inadequate Levothyroxine Replacement [Срок оценки: 1 month after total thyroidectomy]

Вторичные конечные точки (2)

• Correlation Between Smart Wristband Physiological Data and Thyroid Function Tests [Срок оценки: 1 month after total thyroidectomy]
• Prediction of Levothyroxine Dose Adjustment [Срок оценки: 1 month after total thyroidectomy]

Критерии участия

Критерии включения

Age 18 years or older. Undergoing total thyroidectomy at the Department of General Surgery, Yeditepe University Faculty of Medicine Hospital.

Initiation of levothyroxine as part of routine postoperative clinical care. Willing and able to attend the routine 1-month postoperative thyroid function test follow-up visit.

Willing and able to wear the Xiaomi Smart Band 10 throughout the study period. Able to provide written informed consent.

Критерии исключения

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 smart wristband as required. Missing clinical or laboratory data required for outcome assessment. Refusal to participate or withdrawal of informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Yeditepe University Koşuyolu Hospital — Istanbul

Публикации

• Bent B, Goldstein BA, Kibbe WA, Dunn JP. Investigating sources of inaccuracy in wearable optical heart rate sensors. NPJ Digit Med. 2020 Feb 10;3:18. doi: 10.1038/s41746-020-0226-6. eCollection 2020. PMID 32047863
• Wang R, Blackburn G, Desai M, Phelan D, Gillinov L, Houghtaling P, Gillinov M. Accuracy of Wrist-Worn Heart Rate Monitors. JAMA Cardiol. 2017 Jan 1;2(1):104-106. doi: 10.1001/jamacardio.2016.3340. No abstract available. PMID 27732703
• Romero-Velez G, Xiao H, Bena JF, Ikejiani DZ, Berber E, Heiden K, Krishnamurthy V, Shin J, Siperstein A, Jin J. Assessing Changes in Nonspecific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism Using a Smartwatch. Endocr Pract. 2025 Mar;31(3):333-338. doi: 10.1016/j.eprac.2024.12.002. Epub 2024 Dec 9. PMID 39662767
• Amin T, Mobbs RJ, Mostafa N, Sy LW, Choy WJ. Wearable devices for patient monitoring in the early postoperative period: a literature review. Mhealth. 2021 Jul 20;7:50. doi: 10.21037/mhealth-20-131. eCollection 2021. PMID 34345627
• Kim KH, Lee J, Ahn CH, Yu HW, Choi JY, Lee HY, Lee WW, Moon JH. Association between Thyroid Function and Heart Rate Monitored by Wearable Devices in Patients with Hypothyroidism. Endocrinol Metab (Seoul). 2021 Oct;36(5):1121-1130. doi: 10.3803/EnM.2021.1216. Epub 2021 Oct 21. PMID 34674500
• Dunn J, Runge R, Snyder M. Wearables and the medical revolution. Per Med. 2018 Sep;15(5):429-448. doi: 10.2217/pme-2018-0044. Epub 2018 Sep 27. PMID 30259801
• Jonklaas J, Bianco AC, Cappola AR, Celi FS, Fliers E, Heuer H, McAninch EA, Moeller LC, Nygaard B, Sawka AM, Watt T, Dayan CM. Evidence-Based Use of Levothyroxine/Liothyronine Combinations in Treating Hypothyroidism: A Consensus Document. Eur Thyroid J. 2021 Mar;10(1):10-38. doi: 10.1159/000512970. Epub 2021 Feb 16. PMID 33777817
• Biondi B. Mechanisms in endocrinology: Heart failure and thyroid dysfunction. Eur J Endocrinol. 2012 Nov;167(5):609-18. doi: 10.1530/EJE-12-0627. Epub 2012 Sep 6. PMID 22956554

Идентификаторы

NCT: NCT07733375 · 20260606Y1173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗