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Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04832230
Acronym
BIOTSA
Enrollment
500
Registered
2021-04-05
Start date
2021-04-15
Completion date
2024-06-15
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acoustic Trauma

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.

Interventions

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.

OTHERQuestionnaire about previous noise exposure

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

OTHEROtoacoustic 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.

Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30.

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.

OTHERMulti-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.

OTHERAssessment 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.

BIOLOGICALBlood 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.

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic traumaThrough study completion, an average of 3 yearsMachine learning analyses will be performed on the whole collected data to identify diagnostic biomarkers.

Countries

France

Contacts

Primary ContactGuillaume ANDEOL, MD, PhD
guillaume.andeol@intradef.gouv.fr178651207

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026