Ireland
--:--IST
Latest
Clinical Trials in France / NCT05312983
Recruiting Not applicable

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

NCT05312983 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-07-28
Last updated
2025-03-03

Condition(s) studied

Presbyacusis

Investigational drug(s) / intervention(s)

Audiological and vestibular testsBlood samplingneurocognitive self-questionnaire

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Laboratoire de correction auditive Paris France Not Yet Recruiting
CEntre de Recherche et d'Innovation en Audiologie Humaine Paris France Recruiting

More Institut Pasteur trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05312983 on ClinicalTrials.gov ↗ ← All trials in France