Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach

1 country

14 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.2 years study duration

First Submitted

Initial submission to the registry

April 1, 2021

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed

10 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed

Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

3.2 years

First QC Date

April 1, 2021

Last Update Submit

November 16, 2022

Conditions

Acoustic Trauma

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Healthy individuals

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

Other: Hearing testOther: Questionnaire about previous noise exposureOther: Otoacoustic emission measurementOther: ElectrocochleographyOther: Speech audiometry in noiseOther: Multi-frequency impedance measurementBiological: Blood sample collection

Acute acoustic trauma patients

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

Interventions

Hearing testOTHER

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.