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Acoustic TraumaBIOTSANCT04832230

Study of Diagnostic Biomarkers of Acute Acoustic Trauma

An observational study of Acoustic Trauma, run by Direction Centrale du Service de Santé des Armées at 14 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Acoustic Trauma
What is being tested?
Hearing test, Questionnaire about previous noise exposure and Otoacoustic emission measurement
How many people
500 participants
Where
14 sitesFrance
Study dates
15 Apr 2021to 15 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population is composed of healthy individuals who have never been exposed to noise and patients suffering from acute acoustic trauma.

Who may be able to join

  • Age between 18 and 40
  • Healthy individuals: without hearing pathology
  • Patients: acute acoustic trauma diagnosis within 72h

Who cannot join

  • History of hearing pathology
  • History of severe head injury
  • Ototoxic drug therapy
  • Abnormal otoscopy and/or tympanometry

Trial locations and contacts

14 sites in 1 country.

Guillaume ANDEOL, MD, PhD contact

178651207 ext. +33

guillaume.andeol@intradef.gouv.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • 102e Antenne Médicale

    Angoulême, 16021

    Jérémy LE BOHEC, MD, 545224222 ext. +33, jeremy.le-bohec@intradef.gouv.fr

    Recruiting

  • 38e Antenne Médicale

    Bitche, 57230

    Amandine BERCHER, MD, 387063214 ext. +33, amandine.bercher@intradef.gouv.fr

    Recruiting

  • Hôpital d'Instruction des Armées Clermont-Tonnerre

    Brest, 29240

    Alexis MAFFERT, MD, 298437428 ext. +33, alexis.maffert@intradef.gouv.fr

    Recruiting

  • Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées

    Brétigny-sur-Orge, 91223

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

    Recruiting

  • 171e Antenne Médicale

    Caylus, 82160

    Gwenaëlle DEMONT, MD, 563245100 ext. +33, gwenaelle.demont@intradef.gouv.fr

    Recruiting

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92140

    Salomé MARTY, MD, salome.marty@intradef.gouv.fr

    Recruiting

  • 41e Antenne Médicale

    Dieuze, 57260

    Sara CHERRIER, MD, 387058959 ext. +33, sara.cherrier@intradef.gouv.fr

    Recruiting

  • 123e Antenne Médicale

    Guer, 56381

    Aurélie MAILLE, MD, 290404072 ext. +33, aurelie.maille@intradef.gouv.fr

    Recruiting

  • Hôpital d'Instruction des Armées Laveran

    Marseille, 13013

    Pauline PODEUR, MD, 491617265 ext. +33, pauline.podeur@intradef.gouv.fr

    Recruiting

  • 13e Antenne Médicale

    Montlhéry, 91310

    Lenaig LE VOT, MD, 164923589 ext. +33, lenaig.le-vot@intradef.gouv.fr

    Recruiting

  • 109e Antenne Médicale

    Saint-Maixent-l'École, 79400

    Sylviane DE WILDE, MD, 549765385 ext. +33, sylviane.de-wilde@intradef.gouv.fr

    Recruiting

  • 43e Antenne Médicale

    Sarrebourg, 57404

    Sébastien MUTIN, MD, 387234564 ext. +33, sebastien.mutin@intradef.gouv.fr

    Recruiting

  • Hôpital d'Instruction des Armées Sainte-Anne

    Toulon, 83000

    Damien RIVIERE, MD, 483162584 ext. +33, damien.riviere@intradef.gouv.fr

    Not yet recruiting

  • 60e Antenne Médicale

    Valdahon, 25800

    Jordan LACHAUX, MD, 381267413 ext. +33, jordan.lachaux@intradef.gouv.fr

    Recruiting

Other trials in France

About this study

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.

Conditions
Acoustic Trauma
Being tested
Hearing test, Questionnaire about previous noise exposure, Otoacoustic emission measurement, Electrocochleography, Speech audiometry in noise
Medical subject headings
Hearing Loss, Noise-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hearing testOther

    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 exposureOther

    The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).

  • Otoacoustic emission measurementOther

    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.

  • ElectrocochleographyOther

    Healthy individuals: Electrocochleography will be performed at enrollment (Day 0).

    Patients: Electrocochleography will be performed at Day 30.

  • Speech audiometry in noiseOther

    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 measurementOther

    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 severityOther

    Tinnitus severity will be assessed using a visual analogic scale at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.

  • Blood sample collectionBiological

    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.

Study groups in NCT04832230
Study groupRoleWhat they receive
Healthy individualsThis group is composed of healthy individuals without previous noise exposure.
Receives: 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; Biological: Blood sample collection
Acute acoustic trauma patientsThis group is composed of patients suffering from acute acoustic trauma.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start15 Apr 2021
  3. Primary completion15 Jun 2024 (estimated)
  4. Study completion15 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832230
Sponsor's protocol ID
2020PBMD02
Other IDs
2020-A01504-35
Acronym
BIOTSA
Status last verified
Nov 2022
First submitted
1 Apr 2021
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acoustic Trauma, run by Direction Centrale du Service de Santé des Armées at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guillaume ANDEOL, MD, PhD (178651207 ext. +33, guillaume.andeol@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04832230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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