Thyroid Diseases
Conditions
Interventions
Gold Standard:The gold standard tests (TSH, FT4) are independently reported by the laboratory of our hospital.
Index test:By analyzing the user's voice characteristics and integrating clinical information, the AI automatically screens for thyroid dysfunction and predicts the TSH level.
Sponsors
South China Hospital of Shenzhen University
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 20 - 70 years old, gender not restricted; 2. Understand the research content and voluntarily sign the informed consent form, and be able to cooperate in completing voice collection and clinical assessment; 3. Patients who are scheduled to undergo thyroid function tests (serum TSH, FT4, FT3) in outpatient or inpatient settings, or those in the health screening group of the physical examination center; 4. Diagnostic criteria: At the time of enrollment, possess a thyroid function test report within 3 months (as the gold standard reference): Clinical hypothyroidism: TSH > 5.91 mIU/L and FT4 below the lower limit of the normal reference range; Clinical hyperthyroidism: TSH < 0.56 mIU/L and FT4 above the upper limit of the normal reference range; Normal or subclinical group: TSH 0.56 - 5.91 mIU/L and FT3, FT4 within the normal range; 5. After training, master the operation of the voice recorder; 6. Native language: Mandarin Chinese, able to clearly read the 98-character standardized text "The Sounds of the Four Seasons".
Exclusion criteria
Exclusion criteria: 1. Previous history of throat surgery, vocal cord polyps/nodules, or injury to the recurrent laryngeal nerve, etc., indicating organic voice disorders; 2. During the study period, there were acute diseases affecting voice such as acute upper respiratory tract infections and pharyngitis; 3. Throat trauma/structural abnormalities, including 1) vocal cord paralysis: neck trauma, surgical injury (a common complication of thyroid surgery), injury from tracheal intubation, etc., resulting in damage to the recurrent laryngeal nerve and inability of the vocal cords to move normally; 2) laryngeal stenosis: trauma, postoperative sequelae causing scar hyperplasia of laryngeal tissues, narrowing of the airway, accompanied by hoarseness and breathing difficulties. 4. Long-term use of drugs that may affect voice (such as inhaled glucocorticoids, anticholinergic drugs); 5. Suffering from severe cardiopulmonary insufficiency, respiratory failure, etc., unable to complete continuous reading; 6. Individuals with mental disorders or cognitive dysfunction unable to follow instructions; 7. Pregnant or lactating women (physiological fluctuations of thyroid hormones interfere with the baseline); 8. Professional voice users (such as teachers, singers, announcers), with significant variability in the baseline characteristics of their voice; 9. Recording environment not meeting quality control standards (background noise > 30 dB or unable to meet the requirements of a quiet environment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity; | — |
Countries
China
Contacts
Public ContactWu Yang
South China Hospital of Shenzhen University
Outcome results
None listed