Study of Diagnostic Biomarkers of Acute Acoustic Trauma
NCT ID: NCT04832230
Last Updated: 2022-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-04-15
2024-06-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy individuals
This group is composed of healthy individuals without previous noise exposure.
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.
Questionnaire about previous noise exposure
The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).
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.
Electrocochleography
Healthy individuals: Electrocochleography will be performed at enrollment (Day 0).
Patients: Electrocochleography will be performed at Day 30.
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.
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.
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.
Acute acoustic trauma patients
This group is composed of patients suffering from acute acoustic trauma.
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.
Questionnaire about previous noise exposure
The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).
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.
Electrocochleography
Healthy individuals: Electrocochleography will be performed at enrollment (Day 0).
Patients: Electrocochleography will be performed at Day 30.
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.
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.
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.
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.
Interventions
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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.
Questionnaire about previous noise exposure
The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).
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.
Electrocochleography
Healthy individuals: Electrocochleography will be performed at enrollment (Day 0).
Patients: Electrocochleography will be performed at Day 30.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Healthy individuals: without hearing pathology
* Patients: acute acoustic trauma diagnosis within 72h
Exclusion Criteria
* History of severe head injury
* Ototoxic drug therapy
* Abnormal otoscopy and/or tympanometry
18 Years
40 Years
ALL
Yes
Sponsors
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Direction Centrale du Service de Santé des Armées
OTHER
Responsible Party
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Locations
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102e Antenne Médicale
Angoulême, , France
38e Antenne Médicale
Bitche, , France
Hôpital d'Instruction des Armées Clermont-Tonnerre
Brest, , France
Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, , France
171e Antenne Médicale
Caylus, , France
Hôpital d'Instruction des Armées Percy
Clamart, , France
41e Antenne Médicale
Dieuze, , France
123e Antenne Médicale
Guer, , France
Hôpital d'Instruction des Armées Laveran
Marseille, , France
13e Antenne Médicale
Montlhéry, , France
109e Antenne Médicale
Saint-Maixent-l'École, , France
43e Antenne Médicale
Sarrebourg, , France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, , France
60e Antenne Médicale
Valdahon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A01504-35
Identifier Type: OTHER
Identifier Source: secondary_id
2020PBMD02
Identifier Type: -
Identifier Source: org_study_id
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