Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Last updated: November 16, 2022
Sponsor: Direction Centrale du Service de Santé des Armées
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Auditory Loss And Deafness

Treatment

N/A

Clinical Study ID

NCT04832230
2020PBMD02
2020-A01504-35
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18 and 40
  • Healthy individuals: without hearing pathology
  • Patients: acute acoustic trauma diagnosis within 72h

Exclusion

Exclusion Criteria:

  • History of hearing pathology
  • History of severe head injury
  • Ototoxic drug therapy
  • Abnormal otoscopy and/or tympanometry

Study Design

Total Participants: 500
Study Start date:
April 15, 2021
Estimated Completion Date:
June 15, 2024

Connect with a study center

  • 102e Antenne Médicale

    Angoulême, 16021
    France

    Active - Recruiting

  • 38e Antenne Médicale

    Bitche, 57230
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Clermont-Tonnerre

    Brest, 29240
    France

    Active - Recruiting

  • Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées

    Brétigny-sur-Orge, 91223
    France

    Active - Recruiting

  • 171e Antenne Médicale

    Caylus, 82160
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92140
    France

    Active - Recruiting

  • 41e Antenne Médicale

    Dieuze, 57260
    France

    Active - Recruiting

  • 123e Antenne Médicale

    Guer, 56381
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Laveran

    Marseille, 13013
    France

    Active - Recruiting

  • 13e Antenne Médicale

    Montlhéry, 91310
    France

    Active - Recruiting

  • 109e Antenne Médicale

    Saint-Maixent-l'École, 79400
    France

    Active - Recruiting

  • 43e Antenne Médicale

    Sarrebourg, 57404
    France

    Active - Recruiting

  • Hôpital d'Instruction des Armées Sainte-Anne

    Toulon, 83000
    France

    Site Not Available

  • 60e Antenne Médicale

    Valdahon, 25800
    France

    Active - Recruiting

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