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Total ThyroidectomySMART-THYNCT07733375

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

A study testing Xiomi Smart Band 10 in people with Total Thyroidectomy and Hyperthyroidism, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Xiomi Smart Band 10
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Jul 2026to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mustafa Erhan Ayşan, Professor contact

+905322034879

erhan.aysan@yeditepe.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Yeditepe University Koşuyolu Hospital

    Istanbul, Kadıköy, 34718

    Banu Erkal, MD, +905319867061, banu.erkal@yeditepe.edu.tr

    Meltem Bozacı Kılıçoğlu, MD, +905545103809, meltembozaci@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read more

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.

Read the 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.

Being tested
Xiomi Smart Band 10
Keywords
Total Thyroidectomy, Levothyroxine Replacement Therapy, Wearable Devices, Nighttime Heart Rate, Postoperative Hypothyroidism, Postoperative Hyperthyroidism
Medical subject headings
Hyperthyroidism, Hypothyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xiomi Smart Band 10Device

    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.

Study groups in NCT07733375
Study groupRoleWhat they receive
Total Thyroidectomy Patients Receiving LevothyroxineExperimentalAdults 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.
Receives: Device: Xiomi Smart Band 10

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month after total thyroidectomy

Secondary outcomes (2)
  1. Correlation Between Smart Wristband Physiological Data and Thyroid Function Tests

    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.

    Measured: 1 month after total thyroidectomy

  2. Prediction of Levothyroxine Dose Adjustment

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

    Measured: 1 month after total thyroidectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start22 Jul 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
This is a prospective, single-group diagnostic study in which all participants undergo total thyroidectomy and receive standard postoperative levothyroxine replacement therapy. All participants wear a Xiaomi Smart Band 10 during the first postoperative month for continuous monitoring of nighttime heart rate and heart rhythm. The physiological data collected from the wearable device are compared with thyroid function test results obtained at the routine 1-month postoperative follow-up to evaluate the diagnostic performance of wearable-derived parameters in identifying inadequate levothyroxine replacement. No randomization or comparator group is included, and the study intervention does not alter routine clinical management.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07733375
Sponsor's protocol ID
20260606Y1173
Acronym
SMART-THY
Status last verified
Sep 2026
First submitted
24 Jul 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the study involves a single-center observational cohort, and no plans have been made for public data sharing. Participant confidentiality and privacy will be protected in accordance with institutional policies and applicable regulations.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22956554
  • 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.

    PubMed 19906785
  • Klein I, Danzi S. Thyroid disease and the heart. Circulation. 2007 Oct 9;116(15):1725-35. doi: 10.1161/CIRCULATIONAHA.106.678326.

    PubMed 17923583
  • 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.

    PubMed 17991805
  • Verhaert N, Vander Poorten V, Delaere P, Bex M, Debruyne F. Levothyroxine replacement therapy after thyroid surgery. B-ENT. 2006;2(3):129-33.

    PubMed 17067083

Questions about this trial

What is this clinical trial studying?

A study testing Xiomi Smart Band 10 in people with Total Thyroidectomy and Hyperthyroidism, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Banu Erkal, MD (+905319867061, banu.erkal@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Performance of Smart Wristband-Derived Nighttime Heart Rate and Heart Rhythm for Detecting Inadequate Levothyroxine Replacement (time frame: 1 month after total thyroidectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07733375, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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