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临床试验/NCT04832230
NCT04832230招募中不适用

Study of Diagnostic Biomarkers of Acute Acoustic Trauma

Direction Centrale du Service de Santé des Armées14 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年4月15日最近更新:
适应症

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

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

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (14)

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