Study of Diagnostic Biomarkers of Acute Acoustic Trauma (BIOTSA)

November 16, 2022 updated by: Direction Centrale du Service de Santé des Armées

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angoulême, France, 16021
      • Bitche, France, 57230
      • Brest, France, 29240
        • Recruiting
        • Hôpital d'Instruction des Armées Clermont-Tonnerre
        • Contact:
      • Brétigny-sur-Orge, France, 91223
        • Recruiting
        • Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées
        • Contact:
      • Caylus, France, 82160
      • Clamart, France, 92140
      • Dieuze, France, 57260
      • Guer, France, 56381
      • Marseille, France, 13013
      • Montlhéry, France, 91310
      • Saint-Maixent-l'École, France, 79400
      • Sarrebourg, France, 57404
      • Toulon, France, 83000
        • Not yet recruiting
        • Hôpital d'instruction des armées Sainte-Anne
        • Contact:
      • Valdahon, France, 25800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

June 15, 2024

Study Completion (Anticipated)

June 15, 2024

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PBMD02
  • 2020-A01504-35 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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