Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis (SONG)

Sensorion

Status: Enrolling

Conditions: Sensorineural Hearing Loss, Bilateral

Treatments: Other: Audiological assessments; Genetic: Genotyping

Study type: Observational

Funder types: Industry

Identifiers

NCT06354010

SENS-NH02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients with adulthood-onset bilateral sensorineural hearing loss (SNHL)

Treatment:

Genetic: Genotyping

Patients that carry mutations in the gene GJB2 from patients with adulthood-onset bilateral SNHL

Treatment:

Other: Audiological assessments