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

Primary Purpose

Presbyacusis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Audiological and vestibular tests

Blood sampling

neurocognitive self-questionnaire

About this trial

This is an interventional diagnostic trial for Presbyacusis focused on measuring presbyacusis, aging, audiology, genetic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For all participants:

Be over the age of 40,
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:

- Having a hearing aid recipient or coming for a first hearing aid recipient .

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.

Sites / Locations

Laboratoire de correction auditive
CEntre de Recherche et d'Innovation en Audiologie HumaineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

people over the age of 40 who agree to participate in the research.

Arm Description

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 with normal hearing for their age.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT05312983

First Posted

February 25, 2022

Last Updated

September 29, 2023

Sponsor

Institut Pasteur

Collaborators

CEntre de Recherche et d'Innovation en Audiologie Humaine, Laboratoire de correction auditive

1. Study Identification

Unique Protocol Identification Number

NCT05312983

Brief Title

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

Acronym

AUDIOGENAGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2022 (Actual)

Primary Completion Date

July 28, 2024 (Anticipated)

Study Completion Date

July 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Pasteur

Collaborators

CEntre de Recherche et d'Innovation en Audiologie Humaine, Laboratoire de correction auditive

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbyacusis

Keywords

presbyacusis, aging, audiology, genetic

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

2 groups : 500 participants with early onset presbycusis 200 participants with normal hearing for their age

Masking

None (Open Label)

Allocation

N/A

Enrollment

700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

people over the age of 40 who agree to participate in the research.

Arm Type

Experimental

Arm Description

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 with normal hearing for their age.

Intervention Type

Other

Intervention Name(s)

Audiological and vestibular tests

Intervention Description

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

Intervention Name(s)

Blood sampling

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

neurocognitive self-questionnaire

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Normative values for audiological and vestibular tests will be determined

Description

Measurement of values by age range for all audiological and vestibular tests from the results of participants in the control group

Time Frame

4 years and 6 months

Title

Whole-exome sequencing of samples from participants with non-monogenic presbycusis

Description

Whole-exome sequencing will be performed to establish a list of new candidate genes for predisposition to presbycusis.

Time Frame

4 years and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For all participants: Be over the age of 40, 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: - Having a hearing aid recipient or coming for a first hearing aid recipient . 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Celine Quinsac

Phone

+33 (0)1 76 53 50 29

celine.quinsac@pasteur.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Avan, MD

Phone

+33 (0)1 76 53 50 94

paul.avan@uca.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Avan, MD

Organizational Affiliation

CERIAH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratoire de correction auditive

City

Paris

ZIP/Postal Code

75001

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud Coez, PharmD

Phone

+33 (0)1 42 96 87 70

arnaud.coez.ext@pasteur.fr

Facility Name

CEntre de Recherche et d'Innovation en Audiologie Humaine

City

Paris

ZIP/Postal Code

75012

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Avan, MD

Phone

+33 (0)1 76 53 50 94

paul.avan@uca.fr

12. IPD Sharing Statement

Learn more about this trial

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

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