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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Banu Erkal, MD
- Phone Number: +905319867061
- Email: banu.erkal@yeditepe.edu.tr
Study Contact Backup
- Name: Mustafa Erhan Ayşan, Professor
- Phone Number: +905322034879
- Email: erhan.aysan@yeditepe.edu.tr
Study Locations
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Kadıköy
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Istanbul, Kadıköy, Turkey (Türkiye), 34718
- Recruiting
- Yeditepe University Kosuyolu Hospital
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Contact:
- Banu Erkal, MD
- Phone Number: +905319867061
- Email: banu.erkal@yeditepe.edu.tr
-
Contact:
- Meltem Bozacı Kılıçoğlu, MD
- Phone Number: +905545103809
- Email: meltembozaci@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Performance of Smart Wristband-Derived Nighttime Heart Rate and Heart Rhythm for Detecting Inadequate Levothyroxine Replacement
Time Frame: 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.
|
1 month after total thyroidectomy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1 month after total thyroidectomy
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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.
|
1 month after total thyroidectomy
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20260606Y1173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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