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

Sponsor
Yeditepe University Hospital
Study ID
NCT07733375
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Jul 22, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.

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 ]

Central Contacts

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