Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05402813
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2022-05-16
Brief Title:
Natural History in Children up to 10 Years With Moderate to Profound Hearing Loss Due to Mutations in GJB2 OTOF Genes
Sponsor:
Sensorion
Organization:
Sensorion
Study Overview
Official Title:
Longitudinal Study of the Natural History of Two Autosomal Recessive Non Syndromic Deafness DFNB1A and DFNB9 in Children up to 10 Years of Age
Status:
RECRUITING
Status Verified Date:
2023-09
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:
Otoconex
Brief Summary:
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes GJB2 or OTOF in children up to 10 years of age
Detailed Description:
The study aims to
better describe the prevalence of cases of DFNB1A and DFNB9 including the type of mutations and to assess the clinical course of the disease in children up to 10 years of age who have a moderate to profound deafness
better understand the audiological and genetic characteristics of the participants with congenital versus evolutive DFNB1A and DFNB9 deafness
better describe the prevalence of cases of DFNB1A and DFNB9 including the type of mutations and to assess the clinical course of the disease in children up to 10 years of age who have a moderate to profound deafness
better understand the audiological and genetic characteristics of the participants with congenital versus evolutive DFNB1A and DFNB9 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