Recruiting

Observational StudyCross-sectional and Prospective Study to Characterize Early-onset Presbycusis

Sponsor:

Sensorion

Code:

NCT06354010

Conditions

Sensorineural Hearing Loss, Bilateral

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Not accepted

Interventions

Genotyping

Audiological assessments

Study Details

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

Study ID

NCT06354010

Start date

Jun 14, 2024

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 30 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Interventions

Genotyping

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

Audiological assessments

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Lionel HOVSEPIAN, MD

+33786311376 lionel.hovsepian@sensorion-pharma.com

Locations

The University of South Florida Board of Trustees

Recruiting

Tampa, Florida, United States, 33620

More Information

Sponsor

Sensorion

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sensorion on 2026-05-08.