Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Recruiting

• Conditions: Acoustic Trauma

• Registration Number: NCT04832230
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-04-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma	Through study completion, an average of 3 years	Machine learning analyses will be performed on the whole collected data to identify diagnostic biomarkers.

Trial Locations

Locations (14)

102e Antenne Médicale; 🇫🇷 Angoulême, France

38e Antenne Médicale; 🇫🇷 Bitche, France

Hôpital d'Instruction des Armées Clermont-Tonnerre; 🇫🇷 Brest, France

Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées; 🇫🇷 Brétigny-sur-Orge, France

171e Antenne Médicale; 🇫🇷 Caylus, France

Hôpital d'Instruction des Armées Percy; 🇫🇷 Clamart, France

41e Antenne Médicale; 🇫🇷 Dieuze, France

123e Antenne Médicale; 🇫🇷 Guer, France

Hôpital d'Instruction des Armées Laveran; 🇫🇷 Marseille, France

13e Antenne Médicale; 🇫🇷 Montlhéry, France

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