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NCT Number: NCT06354010

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

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.

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Key information

Conditions

Sensorineural Hearing Loss, Bilateral Deafness Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Gui de Chauliac, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genotyping

Genetic

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

Audiological assessments

Other

Audiological assessments

Primary outcomes

  1. 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. 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

Secondary outcomes

  1. Genetic characteristics of adult patients with early-onset presbycusis

    Time frame: Unique visit

    Genotyping

  2. Audiological characteristics of adult patients with early-onset presbycusis

    Time frame: Unique visit

    Pure Tone Audiometry

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lionel HOVSEPIAN, MD

CONTACT

[email protected]

+33786311376

Sponsors and collaborators

Lead sponsor

Sensorion

Industry

Registry information

Acronym: SONG

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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