Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237790
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-12-26
Brief Title:
A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
Sponsor:
Eye ENT Hospital of Fudan University
Organization:
Eye ENT Hospital of Fudan University
Study Overview
Official Title:
A Comparative Analysis of Speech Perception Between Cochlear Implant Patients and DFNB9 Patients Receiving Gene Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Cochlear implant patients exhibit improved speech perception in quiet environments after surgery but their music perception and speech perception under noise are still unsatisfactory Gene therapy is a novel and promising treatment for congenital hearing loss to recover natural hearing sensations To date for patients with congenital deafness there has been no study on their ability to perceive and understand sounds such as speech perception in noise music and directional perception after hearing recovery owing to gene therapy In addition the difference between the two treatments in those perceptual levels postoperatively remains unknown
Therefore the investigators designed a single-center cohort study Based on the intervention method congenital deafness patients are divided into two groups the cochlear implant group and the gene therapy group In the present study a full-scale evaluation of the two groups will be conducted The battery encompasses auditory speech perception cognition psychological status and auditory cortex development A comparative analysis will be conducted to examine multidimensional differences between the two groups shedding light on the divergent outcomes of gene therapy and cochlear implants for patients with congenital deafness
Therefore the investigators designed a single-center cohort study Based on the intervention method congenital deafness patients are divided into two groups the cochlear implant group and the gene therapy group In the present study a full-scale evaluation of the two groups will be conducted The battery encompasses auditory speech perception cognition psychological status and auditory cortex development A comparative analysis will be conducted to examine multidimensional differences between the two groups shedding light on the divergent outcomes of gene therapy and cochlear implants for patients with congenital deafness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None