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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01504-35 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy individuals | This group is composed of healthy individuals without previous noise exposure. |
| |
| Acute acoustic trauma patients | This group is composed of patients suffering from acute acoustic trauma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing test | Other | The hearing test is composed of several examinations:
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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is composed of healthy individuals who have never been exposed to noise and patients suffering from acute acoustic trauma.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume ANDEOL, MD, PhD | Contact | 178651207 | +33 | guillaume.andeol@intradef.gouv.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 102e Antenne Médicale | Recruiting | Angoulême | 16021 | France |
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| Questionnaire about previous noise exposure | Other | The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0). |
|
| Otoacoustic emission measurement | Other | 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 | Other | Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30. |
|
| Speech audiometry in noise | Other | 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 | Other | 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 | Other | 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 | Biological | 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. |
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| 38e Antenne Médicale | Recruiting | Bitche | 57230 | France |
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| Hôpital d'Instruction des Armées Clermont-Tonnerre | Recruiting | Brest | 29240 | France |
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| Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées | Recruiting | Brétigny-sur-Orge | 91223 | France |
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| 171e Antenne Médicale | Recruiting | Caylus | 82160 | France |
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| Hôpital d'Instruction des Armées Percy | Recruiting | Clamart | 92140 | France |
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| 41e Antenne Médicale | Recruiting | Dieuze | 57260 | France |
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| 123e Antenne Médicale | Recruiting | Guer | 56381 | France |
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| Hôpital d'Instruction des Armées Laveran | Recruiting | Marseille | 13013 | France |
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| 13e Antenne Médicale | Recruiting | Montlhéry | 91310 | France |
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| 109e Antenne Médicale | Recruiting | Saint-Maixent-l'École | 79400 | France |
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| 43e Antenne Médicale | Recruiting | Sarrebourg | 57404 | France |
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| Hôpital d'Instruction des Armées Sainte-Anne | Not yet recruiting | Toulon | 83000 | France |
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| 60e Antenne Médicale | Recruiting | Valdahon | 25800 | France |
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| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006309 | Hearing |
| D009622 | Noise |
| ID | Term |
|---|---|
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D004787 | Environmental Pollution |
| D011634 | Public Health |
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