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

NCT06354010 | Recruiting

• 1 other identifier: SENS-NH02
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

Adulthood-onset bilateral sensorineural hearing loss; GJB2; Presbycusis; hearing impairement; Deafness; Connexin 26; SONG; Genetic deafness; Adult deafness

Outcome Measures

Primary Outcomes (2)

• Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene.

  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

  Evolution of hearing impairment assessed by Speech in noise

  2 years

Secondary Outcomes (3)

• Genetic characteristics of adult patients with early-onset presbycusis

  Unique visit

• Audiological characteristics of adult patients with early-onset presbycusis

  Unique visit

• Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene

  2 years

Study Arms (2)

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

Genetic: Genotyping

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

Other: Audiological assessments

Interventions

Genotyping GENETIC

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

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

Audiological assessments OTHER

Audiological assessments

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

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensorion: lead

Study Sites (2)

The University of South Florida Board of Trustees

Tampa, Florida, 33620, United States

RECRUITING

CHU Gui de Chauliac

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Presbycusis; Deafness

Interventions

Genotype

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Frederic Venail, Pr

  CHU Montpellier - Hôpital Gui de Chauliac

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel HOVSEPIAN, MD

CONTACT

+33786311376; lionel.hovsepian@sensorion-pharma.com

Géraldine HONNET, MD

CONTACT

geraldine.honnet@sensorion-pharma.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: April 9, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1)