PresbyacusisAUDIOGENAGENCT05312983
Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss
A study testing Audiological and vestibular tests, Blood sampling and neurocognitive self-questionnaire in people with Presbyacusis, run by Institut Pasteur at 2 sites in France.
Trial summary
Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyacusis
- What is being tested?
- Audiological and vestibular tests, Blood sampling and neurocognitive self-questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jul 2022to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants:
- Be over the age of 18,
- Be affiliated to a social security system,
- Have a good command of the French language (oral and written).
- For the group of participants with anticipated presbycusis:
- Over the age of 40, having a hearing aid recipient or coming for a first hearing aid recipient
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- Between 18 and 40, having a hearing aid recipient, coming for a first hearing aid recipient or declare a progressive genetic birth defect
- For healthy volunteers:
- Have no known hearing loss.
Who cannot join
- Report having been chronically exposed to loud sounds.
- Have a history of ototoxic substances,
- To have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing or balance,
- Have an ethnic origin for which the Pasteur Institute does not have information on the frequency of variants of the genes studied.
- Have type II diabetes,
- Have a neurological or psychiatric condition that interferes with comprehension or ability to move,
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- Be under guardianship,
- Be deprived of liberty by judicial or administrative decision, or be subject to legal protection,
- Not being subject to a social security system,
- Taking narcotic substances, alcohol or medication that diminishes cognitive abilities.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Laboratoire de correction auditive
Paris, 75001
Arnaud Coez, PharmD, +33 (0)1 42 96 87 70, arnaud.coez.ext@pasteur.fr
- Recruiting
CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris, 75012
Paul Avan, MD, +33 (0)1 76 53 50 94, paul.avan@uca.fr
About this study
Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle.
Furthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis.
The collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting.
Read the detailed description
The AUDIOGENAGE project is a multi-center, non-invasive case-control study conducted by CERIAH (CEntre de Recherche et d'Innovation en Human Audiology) and LCA (Laboratory de correction auditive) in 700 volunteer participants identified in two groups:
- 500 Patients with age-related hearing loss of anticipated onset,
- 200 Control subjects, considered as normal hearing for their age at inclusion.
All participants will undergo 6h audiological and vestibular tests, and also neurocognitive test (self-questionnaire). These tests will be conducted over 2 to 4 visits. A 10 mL-blood sample will be collected for a genetic analysis.
- Conditions
- Presbyacusis
- Being tested
- Audiological and vestibular tests, Blood sampling, neurocognitive self-questionnaire
- Keywords
- presbyacusis, aging, audiology, genetic
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiological and vestibular testsOther
6h of audiological and vestibular tests divide in 3 sessions :
- Session A : objective audiological tests
- Session B ; subjective audiological tests
- Session C : balance tests.
Blood samplingOther
A 10 mL blood sample will be collected during the study.
neurocognitive self-questionnaireOther
Four self-questionnaires to fill out to measure sleep quality, memory and emotional state
| Study group | Role | What they receive |
|---|---|---|
| people over the age of 18 who agree to participate in the research. | Experimental | They are either people who have a hearing loss about 20 years older than their age and wear a hearing aid (or come in for a hearing aid), or people over the age of 40 with normal hearing for their age. Receives: Other: Audiological and vestibular tests; Other: Blood sampling; Other: neurocognitive self-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of specificity and sensitivity of the audiological test battery in participants with early-onset presbycusis after identification of pathogenic variants by sequencing and division into subgroups.
specifity and sensitivity will be calculated to identify which tests or combinations of audiological and vestibular tests will be the most discriminating in characterizing each functional module of hearing from participants with monogenic forms of presbycusis of anticipated onset, each affecting a determined functional module, in comparison with an age-matched control group.
Measured: 2 years
Secondary outcomes (2)
Normative values for audiological and vestibular tests will be determined
Measurement of values by age range for all audiological and vestibular tests from the results of participants in the control group
Measured: 4 years and 6 months
Whole-exome sequencing of samples from participants with non-monogenic presbycusis
Whole-exome sequencing will be performed to establish a list of new candidate genes for predisposition to presbycusis.
Measured: 4 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start28 Jul 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyacusisStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 2 groups : * 500 participants with early onset presbycusis * 200 participants with normal hearing for their age
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEntre de Recherche et d'Innovation en Audiologie Humaine, Laboratoire de correction auditive
- Responsible party
- Sponsor
- Investigators
- Paul Avan, MD, Principal investigator, CERIAH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312983
- Sponsor's protocol ID
- 2021-062
- Other IDs
- 2021-A02543-38
- Acronym
- AUDIOGENAGE
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss
- ClinicalTrials.gov ID
- NCT05312983
- Acronym / sponsor ID
- AUDIOGENAGE / 2021-062
- Conditions
- Presbyacusis
- Keywords
- presbyacusis, aging, audiology, genetic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- CEntre de Recherche et d'Innovation en Audiologie Humaine, Laboratoire de correction auditive
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Apr 2022 (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.
Age-related hearing loss, or presbycusis, is caused by many genetic and environmental factors. Its prevalence poses a public health challenge of early identification and effective hearing aid treatment. However, the lack of screening and of a validated audiological test battery to diagnose an individual's needs and to guide hearing aid adjustments is a major obstacle.
Furthermore, monogenic forms of hearing loss affect only one functional module of hearing. The audiological test(s) dependent on the function of this module are affected, in a progressive manner, but not the others. A previous study showed that in early onset presbycusis patients, a quarter of the subjects tested were affected by monogenic presbycusis.
The collection of audiological and vestibular tests, carried out on proven monogenic presbycusis patients and compared to that of normal hearing patients, would constitute a battery of tests allowing a precision diagnosis, then developed to all forms of presbycusis in order to study if the identification of abnormal functional modules can usefully guide the diagnosis and the early fitting.
Detailed description
The AUDIOGENAGE project is a multi-center, non-invasive case-control study conducted by CERIAH (CEntre de Recherche et d'Innovation en Human Audiology) and LCA (Laboratory de correction auditive) in 700 volunteer participants identified in two groups:
- 500 Patients with age-related hearing loss of anticipated onset,
- 200 Control subjects, considered as normal hearing for their age at inclusion.
All participants will undergo 6h audiological and vestibular tests, and also neurocognitive test (self-questionnaire). These tests will be conducted over 2 to 4 visits. A 10 mL-blood sample will be collected for a genetic analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 groups : * 500 participants with early onset presbycusis * 200 participants with normal hearing for their age
| Arm | Type | Receives |
|---|---|---|
| people over the age of 18 who agree to participate in the research. | Experimental | Other: Audiological and vestibular tests, Other: Blood sampling, Other: neurocognitive self-questionnaireThey are either people who have a hearing loss about 20 years older than their age and wear a hearing aid (or come in for a hearing aid), or people over the age of 40 with normal hearing for their age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be over the age of 18,
- Be affiliated to a social security system,
- Have a good command of the French language (oral and written).
- Over the age of 40, having a hearing aid recipient or coming for a first hearing aid recipient
- Between 18 and 40, having a hearing aid recipient, coming for a first hearing aid recipient or declare a progressive genetic birth defect
Key exclusion criteria (10 listed)
- Report having been chronically exposed to loud sounds.
- Have a history of ototoxic substances,
- To have sequelae of ear infections and/or a history of ENT disease that permanently affects hearing or balance,
- Have an ethnic origin for which the Pasteur Institute does not have information on the frequency of variants of the genes studied.
- Have type II diabetes,
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 |
|---|---|---|
| Audiological and vestibular tests6h of audiological and vestibular tests divide in 3 sessions : * Session A : objective audiological tests * Session B ; subjective audiological tests * Session C : balance tests. | Other | people over the age of 18 who agree to participate in the research. |
| Blood samplingA 10 mL blood sample will be collected during the study. | Other | people over the age of 18 who agree to participate in the research. |
| neurocognitive self-questionnaireFour self-questionnaires to fill out to measure sleep quality, memory and emotional state | Other | people over the age of 18 who agree to participate in the research. |
Primary outcome
Measurement of specificity and sensitivity of the audiological test battery in participants with early-onset presbycusis after identification of pathogenic variants by sequencing and division into subgroups.
Time frame: 2 years
specifity and sensitivity will be calculated to identify which tests or combinations of audiological and vestibular tests will be the most discriminating in characterizing each functional module of hearing from participants with monogenic forms of presbycusis of anticipated onset, each affecting a determined functional module, in comparison with an age-matched control group.
2 secondary outcomes
Normative values for audiological and vestibular tests will be determined
Time frame: 4 years and 6 months
Whole-exome sequencing of samples from participants with non-monogenic presbycusis
Time frame: 4 years and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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.
Paul Avan, MD principal investigator
CERIAH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiological and vestibular tests, Blood sampling and neurocognitive self-questionnaire in people with Presbyacusis, run by Institut Pasteur at 2 sites in France.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Mar 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celine Quinsac (+33 (0)1 76 53 50 29, celine.quinsac@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of specificity and sensitivity of the audiological test battery in participants with early-onset presbycusis after identification of pathogenic variants by sequencing and division into subgroups. (time frame: 2 years). 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 3 Mar 2025.