Evaluation of Levothyroxine Replacement Therapy After Total Thyroidectomy Using a Smart Wristband
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYeditepe University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Xiomi Smart Band 10
DeviceParticipants 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Total Thyroidectomy Patients Receiving LevothyroxineExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 month after total thyroidectomySecondary outcomes
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.
Time frame
1 month after total thyroidectomy2
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.
Time frame
1 month after total thyroidectomySponsors and contacts
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Source ClinicalTrials.gov