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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06354010
Other study ID # SENS-NH02
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date July 2027

Study information

Verified date May 2024
Source Sensorion
Contact Judith LAREDO, PhD
Phone +33(0)663737108
Email judith.laredo@sensorion-pharma.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to characterize and assess the evolution of hearing impairment of patients with adulthood-onset bilateral sensorineural hearing loss carrying mutations on GJB2 gene.


Description:

This study aims to characterize patients with adulthood-onset bilateral sensorineural hearing loss not due to any underlying medical condition (likely due to a genetic cause) and to assess the evolution of hearing impairment of those carrying mutations in GJB2 gene. Patients who present with adulthood-onset bilateral sensorineural hearing loss will be screened for the presence of mutation involved in hearing impairment. Patients with GJB2 mutations will be proposed to continue in a follow-up period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 2027
Est. primary completion date July 2027
Accepts healthy volunteers No
Gender All
Age group 30 Years to 55 Years
Eligibility Inclusion Criteria: 1. Female or Male patients =30 and =55 years old 2. Bilateral hearing loss first noticed after the age of 16 years old 3. Documented genotyping results showing mutations in GJB2 gene. Exclusion Criteria: 1. Deafness with a known, non-genetic cause 2. To the opinion of the investigator, unable and/or unwilling to comply with all the protocol requirements and/or study procedures

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Genotyping
Genotyping to determine if patients present mutations to the gene GJB2.
Other:
Audiological assessments
Audiological assessments

Locations

Country Name City State
France CHU Gui de Chauliac Montpellier

Sponsors (1)

Lead Sponsor Collaborator
Sensorion

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene. Evolution of hearing impairment assessed by Pure Tone Audiometry 2 years
Primary Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene Evolution of hearing impairment assessed by Speech in noise 2 years
Secondary Genetic characteristics of adult patients with early-onset presbycusis Genotyping Unique visit
Secondary Audiological characteristics of adult patients with early-onset presbycusis Pure Tone Audiometry Unique visit
Secondary Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene Mood evaluation assessed with Patient Health Questionnaire for depression (PHQ-9) 2 years
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