跳至主要内容
临床试验/NCT04749524
NCT04749524已完成不适用

Otoacoustic Emission Suppression in Clinical Populations

Intelligent Hearing Systems1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
1
主要终点
Otoacoustic Suppression Measure

研究概览

简要总结

The focus of this project is on a physiologic auditory response called the Medial Olivocochlear Reflex (MOCR) that assesses peripheral neural function. While neural hearing loss is a significant auditory disorder in patients of all ages, more than 50% of newborn infants are screened with a technology that is not sensitive to abnormalities in neural function. The development of a time-efficient and sensitive test system to assess the MOCR will provide significant benefit to infants and patients of all ages with neural deficits who would otherwise go undetected.

详细描述

The objective of this study is to develop an optimized hearing testing method using otoacoustic emissions, that can be used to efficiently assess peripheral neural function (including retrocochlear disorders) using the medial olivocochlear reflex (MOCR). Measuring neural function via the MOCR. This reflex has been shown to be abnormal in patients with neural disorders. The focus of this project will be the development of a screening method that incorporates OAE screening and measurement of the MOCR in the same test procedure. The target population in the proposed research is infants, particularly those in environments where auditory brainstem response (ABR) screening is not performed routinely. Addition of the MOCR to screening where ABR is not performed will address the shortcoming of OAE screening which misses neural forms of hearing loss.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Normal middle-ear function
  • Present TEOAEs.

排除标准

  • Atresia or other external ear abnormalities not allowing recording of OAEs

结局指标

主要结局

Otoacoustic Suppression Measure

时间窗: Within 48 hours of measurement

The decibel (dB) Sound Pressure Level (SPL) of the otoacoustic emission (OAE) response will be measured when recorded with and without an elicitor. The dB difference between the two measures, the OAE suppression, is used to calculate the Medial-Olivocochlear Reflex (MOCR) Strength. The elicitor is presented using a temporally separated and spectrally separated method, resulting in the two MOCR Strength measurements reported.

次要结局

未报告次要终点

研究者

发起方
Intelligent Hearing Systems
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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