None listed
Conditions
Interventions
Medical Device : During the clinical trial, participants wear the wearable device and undergo thyroid function tests three times at one-month intervals.
Sponsors
Thyroscope
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 22 or older, both male and female, who have been newly diagnosed or are undergoing treatment for thyroid dysfunction. 2) Individuals who can listen to and understand the explanation of the testing medical device provided at the screening visit and can use it. 3) Individuals who themselves or through a legal guardian have voluntarily decided to participate in this clinical trial and have signed the informed consent form for research participation.
Exclusion criteria
Exclusion criteria: 1) Individuals exhibiting heart conditions such as arrhythmia, heart failure, etc. 2) Individuals who are continuously taking medications that affect heart rate, such as all types of antiarrhythmic drugs, antihistamines, etc. (Intermittent use of beta-blockers with rapid efficacy for symptom relief of hyperthyroidism is permissible.) 3) Women who are pregnant or breastfeeding (those who have plans for pregnancy during the clinical trial period or do not agree to appropriate contraceptive methods) - Appropriate contraceptive methods: Non-hormonal contraceptives medically permitted during pregnancy (male or female condoms, intrauterine devices, spermicides, etc.), hormonal contraceptives (injectable contraceptives, oral contraceptives, etc.), are prohibited. 4) In cases where the occurrence of a significant illness unrelated to research participation makes sufficient follow-up observation difficult or following instructions from the principal investigator leading the clinical trial is impractical. 5) Individuals with severe mental disorders, substance dependence, or alcohol dependence. 6) Other individuals deemed by the investigator to have difficulty conducting this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| F1 score | — |
Secondary
| Measure | Time frame |
|---|---|
| ensitivity and specificity; Area Under the Curve (AUC) | — |
Countries
Korea, Republic of
Contacts
Public ContactDongYeob Shin
Yonsei University Health System, Severance Hospital
Outcome results
None listed