Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Study Overview
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Brief Summary
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Every year, more than two thousand acute acoustic trauma occur in France, equally between the military and the civilian environment. Currently, acute acoustic trauma is a pathology with no specific validated treatment, and it is the cause of many handicapping situations. Improving the future of patients requires a better understanding of the neurophysiological mechanisms of noise-induced hearing impairment. They are multiple and pure tone audiometry, the only reference examination, does not allow to differentiate them. Moreover, in the aftermath of acute acoustic trauma, pure tone audiometry tends to improve spontaneously, but this recovery is misleading, as a number of studies in animals have shown that irreversible lesions remain. The hypothesis of this study is that it is possible to identify new entities, specific to the type of cochlear lesions, in order to clarify the diagnosis of acute acoustic trauma. These entities will be identified by the evaluation of noise-induced hearing impairment via a combination of molecular (proteomic and genomic), physiological and behavioral data. These diagnostic details may then be used to improve prevention or therapy.

Official Title
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Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Conditions
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Acoustic Trauma

Intervention / Treatment
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* Other: Hearing test
* Other: Questionnaire about previous noise exposure
* Other: Otoacoustic emission measurement
* Other: Electrocochleography
* Other: Speech audiometry in noise
* Other: Multi-frequency impedance measurement
* Other: Assessment of tinnitus severity
* Biological: Blood sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 40 Healthy individuals: without hearing pathology Patients: acute acoustic trauma diagnosis within 72h Exclusion Criteria: History of hearing pathology History of severe head injury Ototoxic drug therapy Abnormal otoscopy and/or tympanometry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy individuals<br>This group is composed of healthy individuals without previous noise exposure. | Other: Hearing test<br>* The hearing test is composed of several examinations: pure tone audiogram otoscopy tympanometry Healthy individuals: The hearing test will be performed at enrollment (Day 0). Patients: The hearing test will be performed at Day 1, Day 3, Day 7 and Day 30.<br>Other: Questionnaire about previous noise exposure<br>* The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).<br>Other: Otoacoustic emission measurement<br>* Healthy individuals: Otoacoustic emission will be measured at enrollment (Day 0). Patients: Otoacoustic emission will be measured at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>Other: Electrocochleography<br>* Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.<br>Other: Speech audiometry in noise<br>* Healthy individuals: Speech audiometry in noise will performed at enrollment (Day 0). Patients: Speech audiometry in noise will performed at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>Other: Multi-frequency impedance measurement<br>* Healthy individuals: Multi-frequency impedance will be measured at enrollment (Day 0). Patients: Multi-frequency impedance will be measured at Day 30.<br>Biological: Blood sample collection<br>* Healthy individuals: A blood sample will be collected at enrollment (Day 0). Patients: A blood sample will be collected at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>|
| Acute acoustic trauma patients<br>This group is composed of patients suffering from acute acoustic trauma. | Other: Hearing test<br>* The hearing test is composed of several examinations: pure tone audiogram otoscopy tympanometry Healthy individuals: The hearing test will be performed at enrollment (Day 0). Patients: The hearing test will be performed at Day 1, Day 3, Day 7 and Day 30.<br>Other: Questionnaire about previous noise exposure<br>* The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).<br>Other: Otoacoustic emission measurement<br>* Healthy individuals: Otoacoustic emission will be measured at enrollment (Day 0). Patients: Otoacoustic emission will be measured at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>Other: Electrocochleography<br>* Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.<br>Other: Speech audiometry in noise<br>* Healthy individuals: Speech audiometry in noise will performed at enrollment (Day 0). Patients: Speech audiometry in noise will performed at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>Other: Multi-frequency impedance measurement<br>* Healthy individuals: Multi-frequency impedance will be measured at enrollment (Day 0). Patients: Multi-frequency impedance will be measured at Day 30.<br>Other: Assessment of tinnitus severity<br>* Tinnitus severity will be assessed using a visual analogic scale at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>Biological: Blood sample collection<br>* Healthy individuals: A blood sample will be collected at enrollment (Day 0). Patients: A blood sample will be collected at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma | Machine learning analyses will be performed on the whole collected data to identify diagnostic biomarkers. | Through study completion, an average of 3 years |