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临床试验/NCT04198909
NCT04198909招募中不适用

Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
220
试验地点
2
主要终点
Latency of wave I by electrocochleography

研究概览

简要总结

Acoustic overexposure can induced temporary or hearing loss. Usually hearing loss is associated with cochlear cell damages. Recently, a new pathological entity was described and called "hidden hearing loss". In animal model, the histopathology revealed a selective reduction in the number of auditory fibers, resulting in a decrease in the amplitude of wave I of the auditory brainstem response. Electrocochleography (Ecog) is a method for recording the electrical potentials of the cochlea (e.g. wave I). In clinical routine, Ecog is performed invasively with sedation or local anesthesia. Actually, a non invasive approach could be perform but it seems necessary to optimize this method and to define reference values in healthy volunteers.

详细描述

The sound overexposure is a major cause of hearing disorders. The installation of hearing disorders can be temporary or permanent. Most of the time the investigators see a rise in hearing thresholds that can be accompanied by tinnitus. However, sometimes-hearing disorders aren't characterized by higher auditory threshold but by a complaint of understanding in noise. Two explanation are the either possible with a lesion at the peripheral level (sensory organ) or central lesion (auditory pathways). Peripheral damage is easily analysed by conventional tests such as the audiogram. Concerning the central lesions, through to the Electrocochleography, one sees a diminution of the wave I which corresponds to the nerve fiber injury. The wave I can more easily be analysed by the Electrocochleography method. This technique previously used an electrode deposited trans-tympanically in contact with the sensory organ. But, the evolution of a non-invasive technique is now available. However, several assemblies of the electrode are then possible without knowing the impact of these on the morphology of the wave I. Moreover, no normative values are also referenced in the literature on the population without hearing problems. It's in this context that clinical study is carried out in order to optimize the technique on the assembly of the electrode and the acoustic stimulation delivered. After this analyses and obtaining an optimal technique it's envisaged to study the morphology of the wave I in healthy volunteers aged 18-25 years. A pre-inclusion visit will verify the volunteers doesn't have a hearing disorders through a questionnaire, otoscopy, tympanometry and audiometry. Then two steps will be realized. The first is to evaluate the morphology of wave I according to assembly of electrode and acoustic stimulation delivered (machine calibration or calibration in the external auditory canal). The second step will provide normative values for people 18-25 years old who aren't hearing-impaired. Volunteers will have the choice to participate in one or both stages. The aim is to obtain wave I reference values for Electrocochleography technique. The secondary objectives are to analyse the impact of the assembly of the electrode and the adaptation of the acoustic stimulation presented.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18 and 55 years old
  • be affiliated to a social security system
  • understand (oral and written) of the French language
  • be a qualified hearing with normal tympanogram and audiogram

排除标准

  • have a complaint of hearing
  • have a exposure to noise (professional and/or activities)
  • refusal to participate in the study
  • have ear infections and/or ENT medical history
  • have cardiovascular, metabolic, neurological and psychiatric desease
  • being a protected person
  • healthy volunteer who has received compensation equal to or greader than 4500€ in clinical study

研究组 & 干预措施

Cohort 1

Experimental

干预措施: Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways (Diagnostic Test)

结局指标

主要结局

Latency of wave I by electrocochleography

时间窗: Day 360

The wave I analyzed at electrocochleography will allow to obtain the latency (milliseconds) of action potential (AP)

次要结局

  • Hearing thresholds in decibels(Day -1 , Day 180, Day 360)
  • Acoustic reflex thresholds in decibels(Day -1 , Day 180, Day 360)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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