Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis

Sensorineural Hearing Loss, Bilateral Clinical Trial

— SONG  

Official title:

Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354010
• Other study ID #: SENS-NH02
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Sensorion
• Contact: Judith LAREDO, PhD
• Phone: +33(0)663737108
• Email: judith.laredo[@]sensorion-pharma.com
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural
• Presbycusis
• Sensorineural Hearing Loss, Bilateral

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