Actively Recruiting
A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-09-04
180
Participants Needed
6
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with congenital hearing loss with hearing thresholds 65 dB who have received gene therapy (with standardized rehabilitation and follow-up or plan to receive gene therapy) or cochlear implant surgery
- Healthy participants with normal bilateral hearing thresholds (60 dB), matched to treatment groups by age and sex
- Age 6 months or older, any gender
- Native Mandarin Chinese speakers
- Participants and guardians must provide informed consent and agree to follow-up visits
- Ability to communicate effectively with researchers, with guardian assistance
- Guardians must understand the trial and have appropriate expectations of potential benefits
You will not qualify if you...
- Other ear disorders affecting surgery or study outcomes, including middle/inner ear malformations, vestibular-cochlear nerve abnormalities, otitis media, Meniere's disease, etc., confirmed by CT/MRI within 3 months
- Severe congenital diseases
- Severe systemic diseases or acute illnesses such as pulmonary tuberculosis, active hepatitis B or C, herpes zoster infection, pancreatitis, renal insufficiency
- Low immunity, history of immune deficiency, or organ transplantation
- History of neurological or mental disorders like epilepsy or dementia
- Contraindications to surgery or anesthesia including recent cardiovascular or cerebrovascular events and medication allergies
- For gene therapy group: lack of hearing restoration after therapy
- For cochlear implant group: hereditary syndromic deafness or conditions seriously affecting efficacy evaluation
- Any other conditions deemed unsuitable by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
2
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
3
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
4
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
5
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
6
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
Research Team
Y
Yilai Shu, M.D. & Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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