Clinical trial NCT04832230: Study of Diagnostic Biomarkers of Acute Acoustic Trauma
Official title: Study of Diagnostic Biomarkers of Acute Acoustic Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acoustic Trauma
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of healthy individuals who have never been exposed to noise and patients suffering from acute acoustic trauma.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angoulême
country: France
facility: 102e Antenne Médicale
city: Bitche
country: France
facility: 38e Antenne Médicale
city: Brest
country: France
facility: Hôpital d'Instruction des Armées Clermont-Tonnerre
city: Brétigny-sur-Orge
country: France
facility: Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées
city: Caylus
country: France
facility: 171e Antenne Médicale
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Dieuze
country: France
facility: 41e Antenne Médicale
city: Guer
country: France
facility: 123e Antenne Médicale
city: Marseille
country: France
facility: Hôpital d'Instruction des Armées Laveran
city: Montlhéry
country: France
facility: 13e Antenne Médicale
city: Saint-Maixent-l'École
country: France
facility: 109e Antenne Médicale
city: Sarrebourg
country: France
facility: 43e Antenne Médicale
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
city: Valdahon
country: France
facility: 60e Antenne Médicale
Study officials:
References: