Hypothyroidism Clinical Trials

Find Hypothyroidism Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Yeditepe University Koşuyolu Hospital
RECRUITING
Istanbul
Contact Information
Primary
Banu Erkal, MD
banu.erkal@yeditepe.edu.tr
+905319867061
Backup
Mustafa Erhan Ayşan, Professor
erhan.aysan@yeditepe.edu.tr
+905322034879
Time Frame
Start Date: 2026-07-22
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Leads: Yeditepe University Hospital

This content was sourced from clinicaltrials.gov