Study of Diagnostic Biomarkers of Acute Acoustic Trauma (BIOTSA)

  • End date
    Jun 15, 2024
  • participants needed
  • sponsor
    Direction Centrale du Service de Santé des Armées
Updated on 7 October 2022
Accepts healthy volunteers


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.

Condition Acoustic Trauma
Treatment Blood sample collection, Electrocochleography, speech audiometry in noise, Hearing test, Hearing test, Questionnaire about previous noise exposure, Otoacoustic emission measurement, Multi-frequency impedance measurement, Assessment of tinnitus severity
Clinical Study IdentifierNCT04832230
SponsorDirection Centrale du Service de Santé des Armées
Last Modified on7 October 2022


Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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