NCT05312983

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-28
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2022-04-06
• Last updated: 2025-03-03

Locations

2 sites across 1 country: France