跳至主要内容
临床试验/NCT04357704
NCT04357704撤回不适用

Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.

Oticon Medical0 个研究点开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue

研究概览

简要总结

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

详细描述

Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Fluent in local language
  • Normal hearing listener:
  • pure tone threshold > 25dB from 125Hz to 12kHz
  • Cochlear implant recipient
  • bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
  • Digisonic SP® cochlear implants user

排除标准

  • binaural sensitivity threshold < 1000µs

结局指标

主要结局

speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue

时间窗: day 0

SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.

次要结局

  • Preferred jitter in bilateral cochlear implant user(day 0)
  • speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners(day 0)
  • ITD sensitivity in bilateral cochlear implant user(day 0)
  • speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners(day 0)
  • ITD sensitivity in bilateral cochlear implant user(day 0)
  • Preferred jitter in bilateral cochlear implant user(day 0)

研究者

申办方类型
Industry
责任方
Sponsor

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