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

NCT ID: NCT06354010

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-14

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Sensorineural Hearing Loss, Bilateral

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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

Genotyping

Intervention Type GENETIC

Genotyping to determine if patients present mutations to the gene GJB2.

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

Audiological assessments

Intervention Type OTHER

Audiological assessments

Interventions

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Genotyping

Genotyping to determine if patients present mutations to the gene GJB2.

Intervention Type GENETIC

Audiological assessments

Audiological assessments

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sensorion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Venail, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Montpellier - Hôpital Gui de Chauliac

Locations

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The University of South Florida Board of Trustees

Tampa, Florida, United States

Site Status RECRUITING

CHU Gui de Chauliac

Montpellier, , France

Site Status RECRUITING

Countries

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United States France

Central Contacts

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Lionel HOVSEPIAN, MD

Role: CONTACT

+33786311376

Géraldine HONNET, MD

Role: CONTACT

Facility Contacts

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Victoria Sanchez, MD

Role: primary

Frederic Venail, Pr

Role: primary

Other Identifiers

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SENS-NH02

Identifier Type: -

Identifier Source: org_study_id

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