Study of Diagnostic Biomarkers of Acute Acoustic Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 14
- 主要终点
- Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40
- •Healthy individuals: without hearing pathology
- •Patients: acute acoustic trauma diagnosis within 72h
排除标准
- •History of hearing pathology
- •History of severe head injury
- •Ototoxic drug therapy
- •Abnormal otoscopy and/or tympanometry
结局指标
主要结局
Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma
时间窗: Through study completion, an average of 3 years
Machine learning analyses will be performed on the whole collected data to identify diagnostic biomarkers.
次要结局
未报告次要终点
