An interventional study of Audiological and vestibular tests and Blood sampling in Presbyacusis, sponsored by Institut Pasteur. Recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Institut Pasteur · Not applicable, Interventional, and Diagnostic
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.
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:
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.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's planned enrollment of 700 is above the median of 60 across 45 interventional studies indexed under Presbycusis.
Browse Presbycusis studies →Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.
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For all participants:
For the group of participants with anticipated presbycusis:
For healthy volunteers:
Exclusion Criteria:
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.
Other: Audiological and vestibular tests · Other: Blood sampling · Other: neurocognitive self-questionnaire
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
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.
Time frame: 2 years
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
Time frame: 4 years and 6 months
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.
Time frame: 4 years and 6 months
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