NCT04832230

Study of Diagnostic Biomarkers of Acute Acoustic Trauma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acoustic Trauma

Interventions

Type	Name	Description
OTHER	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.
OTHER	Questionnaire about previous noise exposure	The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).
OTHER	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.
OTHER	Electrocochleography	Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.
OTHER	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.
OTHER	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.
OTHER	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.
BIOLOGICAL	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.

Timeline

• Start date: 2021-04-15
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2021-04-05
• Last updated: 2022-11-17

Locations

14 sites across 1 country: France