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Recruiting NCT06354010

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

— Observational Sensorineural Hearing Loss, Bilateral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Genotyping, Audiological assessments.
Who it may be relevant to
Registry conditions: Sensorineural Hearing Loss, Bilateral. Basic parameters: 30 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene. [Time frame: 2 years]
  • Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene [Time frame: 2 years]
Secondary outcome measures (3)
  • Genetic characteristics of adult patients with early-onset presbycusis [Time frame: Unique visit]
  • Audiological characteristics of adult patients with early-onset presbycusis [Time frame: Unique visit]
  • Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Female or Male patients ≥30 and ≤55 years old
  • Bilateral hearing loss first noticed after the age of 16 years old
  • Documented genotyping results showing mutations in GJB2 gene.

Exclusion criteria

  • Deafness with a known, non-genetic cause
  • To the opinion of the investigator, unable and/or unwilling to comply with all the protocol requirements and/or study procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • The University of South Florida Board of Trustees — Tampa
France · 1 center
  • CHU Gui de Chauliac — Montpellier

Identifiers

NCT: NCT06354010 · SENS-NH02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗