DFNB9 hearing loss
Conditions
Interventions
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gene therapy group: Patients with congenital hearing loss receiving gene therapy; Normal hearing group: Individuals with no family history of hearing loss, with behavioral audiometry thresholds in both ears at 0.25, 0.5, 1, 2, 4, and 8 kHz all below 25 dB HL, and an average hearing threshold =6 months, any gender; 3. Subjects/their guardians must be informed about the study before the trial and voluntarily sign a written informed consent form; 4. Subjects/their guardians must have a correct understanding of the trial and have appropriate expectations of benefits.
Exclusion criteria
Exclusion criteria: 1.Presence of other otological diseases that may interfere with the interpretation of study endpoints, e.g., severe middle/inner ear dysplasia or malformations, vestibulo-cochlear nerve abnormalities, acute/chronic otitis media, Meniere’s disease, tympanic membrane perforation at the time of testing, as identified by CT/MRI scans within 3 months. 2.Presence of other severe congenital diseases. 3.Presence of severe systemic diseases or acute exacerbation of any disease, e.g., pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc. 4.Persistent inability to cooperate with examinations or maintain a short period of quiet during testing, e.g., hypersensitivity to sedative drugs, failed sedation; diagnosis of obstructive sleep apnea-hypopnea syndrome, frequent snoring; diagnosis of attention deficit hyperactivity disorder or other neurological/psychiatric disorders. Any other circumstances deemed by the investigator to make the subject unsuitable for participation in this clinical study. 5.Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Signal-to-Noise Ratio;F0 accuracy; | — |
Countries
China
Contacts
Public ContactYilai Shu
Eye & ENT hospital of Fudan University
Outcome results
None listed