RecruitingNCT06237790
A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
Sponsor
Eye & ENT Hospital of Fudan University
Enrollment
180 participants
Start Date
Apr 6, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 6 Months
Inclusion Criteria6
- 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.
Exclusion Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06237790
Related Trials
Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases Network
NCT0245085133 locations
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
NCT049151835 locations
Hearing and Brain Development Cohort in Children and Adolescents
NCT076254621 location
SPI-1005 in Adults Receiving Cochlear Implant
NCT063406336 locations
Perception of Speech in Context by Listeners With Healthy and Impaired Hearing
NCT064659792 locations