Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss
AUDIOGENAGE
2 other identifiers
interventional
700
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedStudy Start
First participant enrolled
July 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
March 3, 2025
February 1, 2025
5.4 years
February 25, 2022
February 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Normative values for audiological and vestibular tests will be determined
4 years and 6 months
Whole-exome sequencing of samples from participants with non-monogenic presbycusis
4 years and 6 months
Study Arms (1)
people over the age of 18 who agree to participate in the research.
EXPERIMENTALThey 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.
Interventions
6h of audiological and vestibular tests divide in 3 sessions : * Session A : objective audiological tests * Session B ; subjective audiological tests * Session C : balance tests.
A 10 mL blood sample will be collected during the study.
Four self-questionnaires to fill out to measure sleep quality, memory and emotional state
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
- CEntre de Recherche et d'Innovation en Audiologie Humainecollaborator
- Laboratoire de correction auditivecollaborator
Study Sites (2)
Laboratoire de correction auditive
Paris, 75001, France
CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris, 75012, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Avan, MD
CERIAH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2022
First Posted
April 6, 2022
Study Start
July 28, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2030
Last Updated
March 3, 2025
Record last verified: 2025-02