Health TrialsbyHealthPanel

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

ConditionSensorineural Hearing Loss, Bilateral
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-55
SponsorSensorion

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Male and female participants aged ≥30 and ≤55 years old with bilateral hearing loss first noticed after the age of 16 years old.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Genotyping

    Genetic

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

  • Audiological assessments

    Other intervention

    Audiological assessments

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Patients with adulthood-onset bilateral sensorineural hearing loss (SNHL)1 intervention
Group B: Patients that carry mutations in the gene GJB2 from patients with adulthood-onset bilateral SNHL1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years

Secondary outcomes

1

Genetic characteristics of adult patients with early-onset presbycusis

Genotyping

Time frame
Unique visit
2

Audiological characteristics of adult patients with early-onset presbycusis

Pure Tone Audiometry

Time frame
Unique visit
3

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

Mood evaluation assessed with Patient Health Questionnaire for depression (PHQ-9)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sensorion

Lead sponsor

Source ClinicalTrials.gov
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