Study of Diagnostic Biomarkers of Acute Acoustic Trauma (BIOTSA)

Direction Centrale du Service de Santé des Armées

Status: Enrolling

Conditions: Acoustic Trauma

Treatments: Other: Electrocochleography; Other: Hearing test; Other: Otoacoustic emission measurement; Biological: Blood sample collection; Other: Questionnaire about previous noise exposure; Other: Speech audiometry in noise; Other: Assessment of tinnitus severity; Other: Multi-frequency impedance measurement

Study type: Observational

Funder types: Other

Identifiers

NCT04832230

2020-A01504-35 (Other Identifier)

2020PBMD02

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Healthy individuals

Description:

This group is composed of healthy individuals without previous noise exposure.

Treatment:

Other: Speech audiometry in noise

Other: Hearing test

Other: Questionnaire about previous noise exposure

Other: Multi-frequency impedance measurement

Biological: Blood sample collection

Other: Electrocochleography

Other: Otoacoustic emission measurement

Acute acoustic trauma patients

Description:

This group is composed of patients suffering from acute acoustic trauma.

Treatment:

Other: Speech audiometry in noise

Other: Hearing test

Other: Questionnaire about previous noise exposure

Other: Assessment of tinnitus severity

Other: Multi-frequency impedance measurement

Biological: Blood sample collection

Other: Electrocochleography

Other: Otoacoustic emission measurement