Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Acoustic Trauma Clinical Trial

— BIOTSA  

Official title:

Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832230
• Other study ID #: 2020PBMD02
• Secondary ID: 2020-A01504-35
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: November 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Guillaume ANDEOL, MD, PhD
• Phone: 178651207
• Email: guillaume.andeol[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acoustic Trauma
• Hearing Loss, Noise-Induced
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	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	109e Antenne Médicale	Saint-Maixent-l'École
France	43e Antenne Médicale	Sarrebourg
France	Hôpital d'Instruction des Armées Sainte-Anne	Toulon
France	60e Antenne Médicale	Valdahon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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