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

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.

Study Overview

• Status: Recruiting
• Conditions: Presbyacusis
• Intervention / Treatment: Other: Audiological and vestibular tests; Other: Blood sampling; Other: neurocognitive self-questionnaire

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celine Quinsac; Phone Number: +33 (0)1 76 53 50 29; Email: celine.quinsac@pasteur.fr
• Study Contact Backup: Name: Paul Avan, MD; Phone Number: +33 (0)1 76 53 50 94; Email: paul.avan@uca.fr

Study Locations

• France
  • Paris, France, 75001
    • Not yet recruiting
    • Laboratoire de correction auditive
    • Contact: Arnaud Coez, PharmD; Phone Number: +33 (0)1 42 96 87 70; Email: arnaud.coez.ext@pasteur.fr
  • Paris, France, 75012
    • Recruiting
    • CEntre de Recherche et d'Innovation en Audiologie Humaine
    • Contact: Paul Avan, MD; Phone Number: +33 (0)1 76 53 50 94; Email: paul.avan@uca.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: people over the age of 18 who agree to participate in the research.; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Collaborators: CEntre de Recherche et d'Innovation en Audiologie Humaine; Laboratoire de correction auditive
• Investigators: Principal Investigator: Paul Avan, MD, CeRIAH

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: genetic; aging; audiology; presbyacusis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Presbycusis
• Other Study ID Numbers: 2021-062; 2021-A02543-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No