A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy

Recruiting now

Conditions studied: Hearing Loss, Genetic Disease, Speech Perception

In brief

This cohort study aims to explore the trends and differences in multidimensional perceptual levels of patients after cochlear implants or gene therapy, as well as to comprehensively assess the efficacy of gene therapy for congenital deafness, thus providing a reference for making a well-rounded postoperative rehabilitation protocol for gene therapy patients.

Key facts

Study ID

NCT06237790

Run by

Eye & ENT Hospital of Fudan University

People needed

180

Starts

2024-04-06

Expected to finish

2026-12-22

Last updated by the study team

2025-09-04

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with congenital hearing loss with hearing thresholds ≥65 dB receive either gene therapy (previously received gene therapy and standardized postoperative rehabilitation and follow-up or plan to receive gene therapy), or cochlear implant surgery. Healthy participants with bilateral hearing thresholds within the normal range (≤20 dB), generally matched to the gene therapy group and the cochlear implant group by age and sex.
• Age ≥ 6 months old, regardless of gender.
• Mandarin Chinese as the native language.
• Participants and their guardians must provide informed consent before the trial, voluntarily sign a written consent form, and commit to follow-up at specified time points.
• Capable of effective communication with researchers under the guardian's assistance and willing to cooperate and comply with the researchers' requirements.
• The participant's guardians should have a correct understanding of the trial and appropriate expectations regarding potential benefits.

You may not qualify if…

• Presence of other otological disorders that may interfere with the surgical outcome or interpretation of study endpoints, such as middle/inner ear dysplasia or malformations that affected the therapeutic effect revealed in CT/MRI scans within 3 months, 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.
• Gene therapy group: gene therapy did not restore hearing; Cochlear implant group: presence of hereditary syndromic deafness or other conditions that seriously affect the efficacy evaluation.
• Any other conditions for which the investigators consider the subject unsuitable for participation in this clinical study.

Where it is running

• Eye & ENT Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.