Yeditepe University Koşuyolu Hospital
Istanbul, Kadıköy, 34718, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07733375
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Istanbul, Kadıköy, 34718, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 month after total thyroidectomy
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.
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.
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.
Interested in participating?
Request InfoYeditepe University Hospital
Other
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
Acronym: SMART-THY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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