Characterizing early-onset hearing loss related to genetic mutations
Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
This study looks at how hearing loss develops in adults with genetic changes in the GJB2 gene to better understand their condition and track their hearing over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | Sensorion Industry-sponsored |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT06354010 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with adulthood-onset bilateral sensorineural hearing loss, specifically those carrying mutations in the GJB2 gene. It aims to characterize the evolution of hearing impairment in these individuals and assess their genetic profiles. Participants will undergo genotyping and audiological assessments to gather comprehensive data on their condition. The study will also include a follow-up period for those identified with GJB2 mutations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 55 with bilateral hearing loss that began after age 16 and have documented GJB2 mutations.
Not a fit: Patients with deafness due to known non-genetic causes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of genetic hearing impairments in adults.
How similar studies have performed: While studies on genetic causes of hearing loss exist, this specific focus on adulthood-onset presbycusis and GJB2 mutations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida and 1 other locations
- The University of South Florida Board of Trustees — Tampa, Florida, United States (Recruiting)
- CHU Gui de Chauliac — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Maya ELZIERE, MD — Hôpital Eureopéen Marseille
- Study coordinator: Lionel HOVSEPIAN, MD
- Email: lionel.hovsepian@sensorion-pharma.com
- Phone: +33786311376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.