Sensorineural Hearing Loss, BilateralSONGNCT06354010
Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
An observational study of Sensorineural Hearing Loss, Bilateral, run by Sensorion at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Genotyping and Audiological assessments
- How many people
- 134 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jun 2024to 13 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
The University of South Florida Board of Trustees
Tampa, Florida, 33620
About this study
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.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- Genotyping, Audiological assessments
- Keywords
- Adulthood-onset bilateral sensorineural hearing loss, GJB2, Presbycusis, hearing impairement, Deafness, Connexin 26, SONG, Genetic deafness, Adult deafness
- Medical subject headings
- Hearing Loss, Sensorineural, Presbycusis, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingGenetic
Genotyping to determine if patients present mutations to the gene GJB2.
Audiological assessmentsOther
Audiological assessments
| Study group | Role | What they receive |
|---|---|---|
| Patients with adulthood-onset bilateral sensorineural hearing loss (SNHL) | Not described Receives: Genetic: Genotyping | |
| Patients that carry mutations in the gene GJB2 from patients with adulthood-onset bilateral SNHL | Not described Receives: Other: Audiological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
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
Measured: 2 years
Secondary outcomes (3)
Genetic characteristics of adult patients with early-onset presbycusis
Genotyping
Measured: Unique visit
Audiological characteristics of adult patients with early-onset presbycusis
Pure Tone Audiometry
Measured: Unique visit
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start14 Jun 2024
- Primary completion11 Aug 2026
- Study completion13 Aug 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensorion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maya ELZIERE, MD, Principal investigator, Hôpital Eureopéen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354010
- Sponsor's protocol ID
- SENS-NH02
- Acronym
- SONG
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional and Prospective Study to Characterize Early-onset Presbycusis
- ClinicalTrials.gov ID
- NCT06354010
- Acronym / sponsor ID
- SONG / SENS-NH02
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Keywords
- Adulthood-onset bilateral sensorineural hearing loss, GJB2, Presbycusis, hearing impairement, Deafness, Connexin 26, SONG, Genetic deafness
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 134 participants (actual)
- Lead sponsor
- SensorionIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 11 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotypingGenotyping to determine if patients present mutations to the gene GJB2. | Genetic | Patients with adulthood-onset bilateral sensorineural hearing loss (SNHL) |
| Audiological assessmentsAudiological assessments | Other | Patients that carry mutations in the gene GJB2 from patients with adulthood-onset bilateral SNHL |
Primary outcome
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene.
Time frame: 2 years
Evolution of hearing impairment assessed by Pure Tone Audiometry
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene
Time frame: 2 years
Evolution of hearing impairment assessed by Speech in noise
3 secondary outcomes
Genetic characteristics of adult patients with early-onset presbycusis
Time frame: Unique visit
Audiological characteristics of adult patients with early-onset presbycusis
Time frame: Unique visit
Mood evaluation in adult patients with early-onset presbycusis carrying mutations in GJB2 gene
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya ELZIERE, MD principal investigator
Hôpital Eureopéen Marseille
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensorineural Hearing Loss, Bilateral, run by Sensorion at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of hearing impairment of adult patients with early-onset presbycusis carrying mutations in GJB2 gene. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.