Study of Diagnostic Biomarkers of Acute Acoustic Trauma (BIOTSA)

• ClinicalTrials.gov Identifier: NCT04832230
• Recruitment Status: Recruiting
• First Posted: April 5, 2021
• Last Update Posted: April 19, 2021
• Sponsor: Direction Centrale du Service de Santé des Armées
• Information provided by (Responsible Party): Direction Centrale du Service de Santé des Armées

Study Description

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.

Condition or disease	Intervention/treatment
Acoustic Trauma	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

Study Design

• Study Type: Observational
• Estimated Enrollment: 500 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Study of Diagnostic Biomarkers of Acute Acoustic Trauma
• Actual Study Start Date: April 15, 2021
• Estimated Primary Completion Date: November 2022
• Estimated Study Completion Date: November 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Healthy individuals; This group is composed of healthy individuals without previous noise exposure.	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.; Other: Questionnaire about previous noise exposure; The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).; Other: 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.; Other: Electrocochleography; Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.; Other: 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.; Other: 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.; 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.
Acute acoustic trauma patients; This group is composed of patients suffering from acute acoustic trauma.	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.; Other: Questionnaire about previous noise exposure; The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).; Other: 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.; Other: Electrocochleography; Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.; Other: 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.; Other: 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.; Other: 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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Contacts

Contact: Guillaume ANDEOL, MD, PhD; 178651207 ext +33; guillaume.andeol@intradef.gouv.fr

Locations

France

43e Antenne Médicale de Sarrebourg; Recruiting

Sarrebourg, France, 57404

Contact: Pierre RAJOELISON, MD 387234509 ext +33 pierre.rajoelison@intradef.gouv.fr

Sponsors and Collaborators

Direction Centrale du Service de Santé des Armées

More Information

• Responsible Party: Direction Centrale du Service de Santé des Armées
• ClinicalTrials.gov Identifier: NCT04832230
• Other Study ID Numbers: 2020PBMD02; 2020-A01504-35 ( Other Identifier: IDRCB )
• First Posted: April 5, 2021
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hearing Loss, Noise-Induced; Wounds and Injuries; Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases