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
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring and comparing how patients perceive sounds after receiving either cochlear implants or gene therapy for congenital deafness. This study aims to understand differences in speech perception in various environments, music appreciation, and directional hearing between these two treatments. By assessing cognitive and psychological factors alongside auditory development, the study hopes to inform better rehabilitation plans for gene therapy patients. The study includes two groups of congenital deafness patients: those who have cochlear implants and those who have undergone gene therapy for autosomal recessive deafness 9 (DFNB9). Patients receive standard postoperative care and follow-up. The evaluation covers multiple aspects such as speech perception in quiet and noisy settings, cognitive function, psychological status, and auditory cortex growth over time. Participants will be assessed before treatment and at weeks 13, 26, and 52 after intervention. Evaluations include tests of auditory speech perception, cognitive abilities, psychological health, and brain development related to hearing. The study requires participants and their guardians to provide informed consent and cooperate with follow-up visits. Healthy individuals with normal hearing are also included as controls. The goal is to compare outcomes between the two treatments over one year.
CONDITIONS
Brief 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 or plan to receive gene therapy or cochlear implant surgery
- Healthy participants with normal bilateral hearing thresholds (40 dB), matched by age and sex
- Age 6 months or older, any gender
- Mandarin Chinese as the native language
- Participants and guardians must provide informed consent and commit to follow-up visits
- Able to communicate effectively with guardian assistance and willing to cooperate with researchers
- Guardians should understand the trial and have appropriate expectations
You will not qualify if you...
- Other ear disorders affecting surgery or study results, such as ear malformations or nerve abnormalities
- Severe congenital diseases
- Severe or acute systemic diseases like active infections or organ failure
- Low immunity, immune deficiency, or history of organ transplant
- History of neurological or mental disorders like epilepsy or dementia
- Contraindications for surgery or anesthesia, including recent cardiovascular events or medication allergies
- For gene therapy group: hearing not restored by gene therapy
- For cochlear implant group: hereditary syndromic deafness or other conditions affecting evaluation
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive either gene therapy or cochlear implant surgery as part of their treatment for congenital hearing loss.
Visits at preoperation, Week 13, Week 26, and Week 52
Duration - Up to 1 year
Participants undergo evaluations of auditory speech perception, cognitive function, psychological status, and auditory cortex development after treatment.
Visits at Week 13, Week 26, and Week 52
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.
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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