Congenital deafness
Conditions
Interventions
Gene therapy group:None
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: ? Patients with congenital hearing loss with hearing thresholds =65 dB receive either gene therapy or cochlear implant surgery. ? Age between 1 and 18 years, regardless of gender. ? Mandarin Chinese as the native language. ? Participants and their guardians must provide informed consent before the trial and voluntarily sign a written consent form. ? Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements. For young children without mature language abilities, they should be able to cooperate and comply with the researcher's requirements with the help of their guardians; ? The participant's guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.
Exclusion criteria
Exclusion criteria: ? Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as vestibular-cochlear nerve abnormalities, acute/chronic otitis media, Meniere's disease, etc. ? Presence of other severe congenital diseases. ? Presence of severe systemic diseases or in the acute onset of diseases, such as pulmonary tuberculosis, active hepatitis B or C infection, active herpes zoster infection, pancreatitis, renal insufficiency, etc. ? Individuals with low immunity, a history of immune deficiency, or organ transplantation. ? Individuals with a history of neurological or mental disorders, such as epilepsy or dementia. ? Patients with contraindications for surgery or anesthesia assessed by a surgeon, anesthetist, or designated personnel, such as cardiovascular or cerebrovascular events in the past 6 months, allergies to the planned medications, etc. ? Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| auditory speech perception; | — |
Secondary
| Measure | Time frame |
|---|---|
| cognitive function;psychological status;auditory cortex development; | — |
Countries
China
Contacts
Public ContactYilai Shu
Eye & ENT Hospital of Fudan University
Outcome results
None listed