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Clinical trial

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

ID
Name
SENS-NH02
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2027-07-01
Trial end
2027-07-01
Status
Not yet recruiting
Treatment
Genotyping
Genotyping to determine if patients present mutations to the gene GJB2.
Arms:
Patients with adulthood-onset bilateral sensorineural hearing loss (SNHL)
Audiological assessments
Audiological assessments
Arms:
Patients that carry mutations in the gene GJB2 from patients with adulthood-onset bilateral SNHL
Size
100
Primary endpoint
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene.
2 years
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene
2 years
Eligibility 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

1 product

2 indications

Product
Genotyping
Indication
Hearing Loss, Sensorineural
Indication
Bilateral
Organization
Sensorion