Study of Diagnostic Biomarkers of Acute Acoustic Trauma
NCT04832230 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2022-11-17
Summary
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.
Conditions
- Acoustic Trauma
Interventions
- OTHER
-
Hearing test
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.
- OTHER
-
Questionnaire about previous noise exposure
The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).
- OTHER
-
Otoacoustic emission measurement
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.
- OTHER
-
Electrocochleography
Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.
- OTHER
-
Speech audiometry in noise
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.
- OTHER
-
Multi-frequency impedance measurement
Healthy individuals: Multi-frequency impedance will be measured at enrollment (Day 0). Patients: Multi-frequency impedance will be measured at Day 30.
- OTHER
-
Assessment of tinnitus severity
Tinnitus severity will be assessed using a visual analogic scale at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.
- BIOLOGICAL
-
Blood sample collection
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.
Sponsors & Collaborators
-
Direction Centrale du Service de Santé des Armées
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-04-15
- Primary Completion
- 2024-06-15
- Completion
- 2024-06-15
Countries
- France
Study Locations
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