Evaluation of Levothyroxine Replacement Therapy After Total Thyroidectomy Using a Smart Wristband (SMART-THY)
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
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Banu Erkal, MD
- 电话号码:+905319867061
- 邮箱:banu.erkal@yeditepe.edu.tr
研究联系人备份
- 姓名:Mustafa Erhan Ayşan, Professor
- 电话号码:+905322034879
- 邮箱:erhan.aysan@yeditepe.edu.tr
学习地点
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Kadıköy
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Istanbul、Kadıköy、土耳其(türkiye)、34718
- 招聘中
- Yeditepe University Kosuyolu Hospital
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接触:
- Banu Erkal, MD
- 电话号码:+905319867061
- 邮箱:banu.erkal@yeditepe.edu.tr
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接触:
- Meltem Bozacı Kılıçoğlu, MD
- 电话号码:+905545103809
- 邮箱:meltembozaci@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
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.
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 smart wristband as required. Missing clinical or laboratory data required for outcome assessment. Refusal to participate or withdrawal of informed consent.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Total Thyroidectomy Patients Receiving Levothyroxine
Adults undergoing total thyroidectomy who receive standard postoperative levothyroxine replacement therapy.
Participants will wear a smart wristband during the early postoperative period to continuously record nighttime heart rate and heart rhythm.
They will undergo routine thyroid function testing, including serum thyroid-stimulating hormone (TSH) and free thyroxine (fT4), 1 month after surgery as part of standard clinical care.
Smart wristband-derived physiological data will be compared with thyroid function test results to evaluate whether wearable monitoring can identify under- or over-replacement with levothyroxine before the routine 1-month biochemical assessment.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic Performance of Smart Wristband-Derived Nighttime Heart Rate and Heart Rhythm for Detecting Inadequate Levothyroxine Replacement
大体时间:1 month after total thyroidectomy
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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.
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1 month after total thyroidectomy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation Between Smart Wristband Physiological Data and Thyroid Function Tests
大体时间:1 month after total thyroidectomy
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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.
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1 month after total thyroidectomy
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Prediction of Levothyroxine Dose Adjustment
大体时间:1 month after total thyroidectomy
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To evaluate whether smart wristband-derived physiological measurements can predict the need for levothyroxine dose adjustment at the first postoperative follow-up visit.
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1 month after total thyroidectomy
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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Flynn RW, Bonellie SR, Jung RT, MacDonald TM, Morris AD, Leese GP. Serum thyroid-stimulating hormone concentration and morbidity from cardiovascular disease and fractures in patients on long-term thyroxine therapy. J Clin Endocrinol Metab. 2010 Jan;95(1):186-93. doi: 10.1210/jc.2009-1625. Epub 2009 Nov 11.
- Klein I, Danzi S. Thyroid disease and the heart. Circulation. 2007 Oct 9;116(15):1725-35. doi: 10.1161/CIRCULATIONAHA.106.678326.
- Biondi B, Cooper DS. The clinical significance of subclinical thyroid dysfunction. Endocr Rev. 2008 Feb;29(1):76-131. doi: 10.1210/er.2006-0043. Epub 2007 Nov 8.
- Verhaert N, Vander Poorten V, Delaere P, Bex M, Debruyne F. Levothyroxine replacement therapy after thyroid surgery. B-ENT. 2006;2(3):129-33.
研究记录日期
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学习开始 (实际的)
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研究完成 (估计的)
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- 20260606Y1173
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