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

NCT07733375 | Recruiting

• 1 other identifier: 20260606Y1173
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Thyroidectomy; Hyperthyroidism; Hypothyroidism

Keywords

Total Thyroidectomy; Levothyroxine Replacement Therapy; Wearable Devices; Nighttime Heart Rate; Postoperative Hypothyroidism; Postoperative Hyperthyroidism

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Correlation Between Smart Wristband Physiological Data and Thyroid Function Tests

  1 month after total thyroidectomy

• Prediction of Levothyroxine Dose Adjustment

  1 month after total thyroidectomy

Study Arms (1)

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.

Device: Xiomi Smart Band 10

Interventions

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.

Total Thyroidectomy Patients Receiving Levothyroxine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults undergoing total thyroidectomy who require postoperative levothyroxine replacement therapy. Participants will be recruited from the Department of General Surgery at Yeditepe University Koşuyolu Hospital. All participants will receive standard postoperative care and wear a smart wristband during the first postoperative month for continuous monitoring of nighttime heart rate and heart rhythm.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yeditepe University Hospital: lead

Study Sites (1)

Yeditepe University Koşuyolu Hospital

Istanbul, Kadıköy, 34718, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19906785 BACKGROUND

• Klein I, Danzi S. Thyroid disease and the heart. Circulation. 2007 Oct 9;116(15):1725-35. doi: 10.1161/CIRCULATIONAHA.106.678326.

  PMID: 17923583 BACKGROUND

• 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.

  PMID: 17991805 BACKGROUND

• Verhaert N, Vander Poorten V, Delaere P, Bex M, Debruyne F. Levothyroxine replacement therapy after thyroid surgery. B-ENT. 2006;2(3):129-33.

  PMID: 17067083 BACKGROUND

MeSH Terms

Conditions

Hyperthyroidism; Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Banu Erkal, MD

CONTACT

+905319867061; banu.erkal@yeditepe.edu.tr

Mustafa Erhan Ayşan, Professor

CONTACT

+905322034879; erhan.aysan@yeditepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)