ClinicalTrials.gg
TerminatedNCT06354010SONGUpdated Oct 26, 2026

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

An observational study in Sensorineural Hearing Loss, Bilateral, sponsored by Sensorion. Terminated at 2 sites in 2 countries. Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Primary conditionPresbycusisRegistry: Hearing Loss, SensorineuralReclassifiedWhy we changed it
Registry
Hearing Loss, Sensorineural — the first condition term the registry derived for this study.
ClinicalTrials.gg
Presbycusis
Why
  1. The study's title name Presbycusis, a narrower term within Hearing Loss, Sensorineural.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sensorion · Observational

Why this study was terminated
Sponsor decision
Updated Oct 26, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
134
Ages
30 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

This study aims to characterize patients with adulthood-onset bilateral sensorineural hearing loss not due to any underlying medical condition (likely due to a genetic cause) and to assess the evolution of hearing impairment of those carrying mutations in GJB2 gene.

Patients who present with adulthood-onset bilateral sensorineural hearing loss will be screened for the presence of mutation involved in hearing impairment. Patients with GJB2 mutations will be proposed to continue in a follow-up period.

02

Conditions studied

  • Sensorineural Hearing Loss, Bilateral

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Keywords

  • Adulthood-onset bilateral sensorineural hearing loss
  • GJB2
  • Presbycusis
  • hearing impairement
  • Deafness
  • Connexin 26
  • SONG
  • Genetic deafness
  • Adult deafness
03

In context

Presbycusis Reclassified

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's enrollment of 134 is close to the median of 123 across 20 observational studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

Sensorion is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Compared within Presbycusis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss, Sensorineural. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
134 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • GeneticGenotyping

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

  • OtherAudiological assessments

    Audiological assessments

06

What researchers measure

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

07

Study locations

2 sites
  • The University of South Florida Board of Trustees
    Tampa, Florida 33620, United States
  • CHU Gui de Chauliac
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Terminated Sponsor decision
changed Oct 26, 2026
Primary completion
Jul 2027→Aug 11, 2026 (actual)
Oct 26, 2026
Study completion
Jul 2027→Aug 13, 2026 (actual)
Oct 26, 2026
Enrollment
100 (estimated)→134 (actual)
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Recruiting→Terminated
    Why stopped Sponsor decision
    Primary completion Jul 2027→Aug 11, 2026 (now actual)
    Study completion Jul 2027→Aug 13, 2026 (now actual)
    Enrollment 100 (estimated)→134 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06354010
Lead sponsor
Sensorion
Responsible party
Sponsor
First posted
Apr 9, 2024
Start date
Jun 14, 2024
Primary completion
Aug 11, 2026
Completion
Aug 13, 2026
Last update
Oct 26, 2026

Study contacts

Maya ELZIERE, MD
principal investigator · Hôpital Eureopéen Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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