Development of a Battery of Audiological Tests for the Precision Diagnosis of Age-related Hearing Loss
ConditionPresbyacusis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Pasteur
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Be over the age of 18,
Be affiliated to a social security system,
Have a good command of the French language (oral and written).
Over the age of 40, having a hearing aid recipient or coming for a first hearing aid recipient
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Audiological and vestibular tests
Other intervention6h 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
Other interventionA 10 mL blood sample will be collected during the study.
neurocognitive self-questionnaire
Other interventionFour self-questionnaires to fill out to measure sleep quality, memory and emotional state
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: people over the age of 18 who agree to participate in the research.Experimental treatment 3 interventions
Trial outcomes
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.
Time frame
2 yearsSecondary outcomes
1
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 months2
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 monthsSponsors and contacts
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Institut Pasteur
Lead sponsor
CEntre de Recherche et d'Innovation en Audiologie Humaine
Collaborator
Laboratoire de correction auditive
Collaborator
Source ClinicalTrials.gov