Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832230
Status:
RECRUITING
Last Update Posted:
2022-11-17
First Post:
2021-04-01
Brief Title:
Study of Diagnostic Biomarkers of Acute Acoustic Trauma
Sponsor:
Direction Centrale du Service de Santé des Armées
Organization:
Direction Centrale du Service de Santé des Armées
Study Overview
Official Title:
Study of Diagnostic Biomarkers of Acute Acoustic Trauma
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOTSA
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01504-35 | OTHER | IDRCB | None |