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

NCT ID: NCT05312983

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2030-12-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Audiological and vestibular tests

Intervention Type: OTHER

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

Intervention Type: OTHER

A 10 mL blood sample will be collected during the study.

neurocognitive self-questionnaire

Intervention Type: OTHER

Four self-questionnaires to fill out to measure sleep quality, memory and emotional state

Interventions

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.

Intervention Type: OTHER

Blood sampling

A 10 mL blood sample will be collected during the study.

Intervention Type: OTHER

neurocognitive self-questionnaire

Four self-questionnaires to fill out to measure sleep quality, memory and emotional state

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CEntre de Recherche et d'Innovation en Audiologie Humaine

UNKNOWN

Sponsor Role: collaborator

Laboratoire de correction auditive

UNKNOWN

Sponsor Role: collaborator

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Avan, MD

Role: PRINCIPAL_INVESTIGATOR

CERIAH

Locations

Laboratoire de correction auditive

Paris, , France

Site Status: NOT_YET_RECRUITING

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Celine Quinsac

Role: CONTACT

celine.quinsac@pasteur.fr

+33 (0)1 76 53 50 29

Paul Avan, MD

Role: CONTACT

paul.avan@uca.fr

+33 (0)1 76 53 50 94

Facility Contacts

Arnaud Coez, PharmD

Role: primary

arnaud.coez.ext@pasteur.fr

+33 (0)1 42 96 87 70

Paul Avan, MD

Role: primary

paul.avan@uca.fr

+33 (0)1 76 53 50 94

Other Identifiers

2021-A02543-38

Identifier Type: OTHER

Identifier Source: secondary_id

2021-062

Identifier Type: -

Identifier Source: org_study_id