Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss

Presbyacusis Clinical Trial

— AUDIOGENAGE  

Official title:

Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312983
• Other study ID #: 2021-062
• Secondary ID: 2021-A02543-38
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: July 28, 2028

Study information

• Verified date: March 2024
• Source: Institut Pasteur
• Contact: Celine Quinsac
• Phone: +33 (0)1 76 53 50 29
• Email: celine.quinsac[@]pasteur.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 28, 2028
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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
• 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.

Exclusion Criteria:

• 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,
• 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.

Related Conditions & MeSH terms

• Hearing Loss
• Presbyacusis
• Presbycusis

Intervention

Other:
• Audiological and vestibular tests
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 sampling
A 10 mL blood sample will be collected during the study.
• neurocognitive self-questionnaire
Four self-questionnaires to fill out to measure sleep quality, memory and emotional state

Locations

Country	Name	City	State
France	CEntre de Recherche et d'Innovation en Audiologie Humaine	Paris
France	Laboratoire de correction auditive	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Institut Pasteur	CEntre de Recherche et d'Innovation en Audiologie Humaine, Laboratoire de correction auditive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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	4 years and 6 months
Secondary	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.	4 years and 6 months