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

April 2, 2024 updated by: Sensorion
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Gui de Chauliac
        • Contact:
          • Frederic Venail, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male and female participants aged ≥30 and ≤55 years old with bilateral hearing loss first noticed after the age of 16 years old.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with adulthood-onset bilateral sensorineural hearing loss (SNHL)
Genetic: Genotyping
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
Other: Audiological assessments
Audiological assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene.
Time Frame: 2 years
Evolution of hearing impairment assessed by Pure Tone Audiometry
2 years
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene
Time Frame: 2 years
Evolution of hearing impairment assessed by Speech in noise
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic characteristics of adult patients with early-onset presbycusis
Time Frame: Unique visit
Genotyping
Unique visit
Audiological characteristics of adult patients with early-onset presbycusis
Time Frame: Unique visit
Pure Tone Audiometry
Unique visit
Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene
Time Frame: 2 years
Mood evaluation assessed with Patient Health Questionnaire for depression (PHQ-9)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sensorion

Investigators

  • Principal Investigator: Frederic Venail, Pr, CHU Montpellier - Hôpital Gui de Chauliac

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENS-NH02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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