Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Recruiting

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

• 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

Arm && Interventions

Group	Intervention	Description
Healthy individuals	Otoacoustic emission measurement	This group is composed of healthy individuals without previous noise exposure.
Acute acoustic trauma patients	Electrocochleography	This group is composed of patients suffering from acute acoustic trauma.
Acute acoustic trauma patients	Multi-frequency impedance measurement	This group is composed of patients suffering from acute acoustic trauma.
Acute acoustic trauma patients	Hearing test	This group is composed of patients suffering from acute acoustic trauma.
Acute acoustic trauma patients	Blood sample collection	This group is composed of patients suffering from acute acoustic trauma.
Healthy individuals	Multi-frequency impedance measurement	This group is composed of healthy individuals without previous noise exposure.
Acute acoustic trauma patients	Questionnaire about previous noise exposure	This group is composed of patients suffering from acute acoustic trauma.
Acute acoustic trauma patients	Otoacoustic emission measurement	This group is composed of patients suffering from acute acoustic trauma.
Healthy individuals	Questionnaire about previous noise exposure	This group is composed of healthy individuals without previous noise exposure.
Healthy individuals	Hearing test	This group is composed of healthy individuals without previous noise exposure.
Healthy individuals	Electrocochleography	This group is composed of healthy individuals without previous noise exposure.
Healthy individuals	Speech audiometry in noise	This group is composed of healthy individuals without previous noise exposure.
Healthy individuals	Blood sample collection	This group is composed of healthy individuals without previous noise exposure.
Acute acoustic trauma patients	Speech audiometry in noise	This group is composed of patients suffering from acute acoustic trauma.
Acute acoustic trauma patients	Assessment of tinnitus severity	This group is composed of patients suffering from acute acoustic trauma.

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)

38e Antenne Médicale; 🇫🇷 Bitche, France

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

171e Antenne Médicale; 🇫🇷 Caylus, France

41e Antenne Médicale; 🇫🇷 Dieuze, France

13e Antenne Médicale; 🇫🇷 Montlhéry, France

123e Antenne Médicale; 🇫🇷 Guer, France

60e Antenne Médicale; 🇫🇷 Valdahon, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France

102e Antenne Médicale; 🇫🇷 Angoulême, France

109e Antenne Médicale; 🇫🇷 Saint-Maixent-l'École, France

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

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

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

43e Antenne Médicale; 🇫🇷 Sarrebourg, France