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Speech Perception Performance With Gap-interleaved Stimulation Paradigms

2019年9月25日 更新者:Angelica Perez Fornos

Effect of Gap-interleaved Stimulation Paradigms in Speech Perception Performance of Experienced Cochlear Implant Recipients: a Single-centre, Randomised Controlled Single-blinded Study

Cochlear implants (CI) are used to help patients with severe to profound hearing loss regain auditory perception by electrical stimulation of the auditory nerve. The electrical stimulation consists of trains of charge balanced, biphasic current pulses. For each patient, individual stimulation parameters (perception threshold, most comfortable level - MCL) are determined for each electrode during fitting sessions. However, an important parameter, pulse duration, cannot be individualized for each electrode. There are certain circumstances where it would be advantageous to have the possibility of introducing variable pulse durations into the fitting strategy (e.g., optimization of energy consumption, development of combined cochleo-vestibular implants). However, since in current CI systems pulses are transmitted sequentially, introducing varying pulse widths would also introduce "gaps" (zero-stimulation periods) into the stimulation profile. The influence of such auditory gaps on speech recognition and on the quality of hearing has not been explored yet, but can be investigated in current CI users. The objective of this study is to investigate the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.

研究概览

详细说明

Auditory gaps can be induced in standard CI users by temporarily deactivating one to three electrodes. These gaps can be configured to have different gap durations.

The different variations of auditory stimulation with gaps will be presented to study participants via a standard MED-EL audio processor (Opus 2) bearing conformity marking. The programming of the processor will be performed using standard clinical hardware and software interfaces. These include the hardware interfaces "MAX interface box" and the "Diagnostic Interface Box" (DIB II) as well as the "MAESTRO" fitting software. After programming the respective configurations to the audio test-processor, a clinical word recognition test (Fournier) and a clinical consonant recognition test will be presented to the participants in a sound-shielded chamber using a free-field loudspeaker system.

研究类型

介入性

注册 (实际的)

8

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Geneva、瑞士、1205
        • Geneva University Hospitals

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Informed Consent as documented by signature
  • CI recipients using MED-EL implants (C40+, Pulsar, Sonata, Concerto, or Synchrony) and standard electrode arrays (Standard, FLEXSOFT, FLEX28, or FLEX24)
  • >1 year post-implantation
  • Regular CI use (at least 4 hours/day)
  • At least 9 active electrodes in the device
  • Good knowledge of French (at least B1 level according to the Common European Framework of Reference for Languages)

Exclusion Criteria:

  • Patients with electro-acoustic stimulation (EAS) systems
  • Unwillingness or inability to perform investigational tests
  • Known or suspected drug or alcohol abuse
  • Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Cochlear implant recipients
Investigation of the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Performance in standardized speech perception tests
大体时间:Day 1
Consonant and word recognition tests
Day 1

次要结果测量

结果测量
措施说明
大体时间
Comparison of volume levels resulting in equal loudness perception
大体时间:Day 1
Energetic efficiency of stimulation map
Day 1

其他结果措施

结果测量
措施说明
大体时间
Quality of hearing
大体时间:Day 1
1-10 visual-analog scale
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Angelica Perez Fornos, PhD、University Hospital, Geneva

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年3月6日

初级完成 (实际的)

2019年6月28日

研究完成 (实际的)

2019年6月30日

研究注册日期

首次提交

2019年4月30日

首先提交符合 QC 标准的

2019年5月2日

首次发布 (实际的)

2019年5月3日

研究记录更新

最后更新发布 (实际的)

2019年9月26日

上次提交的符合 QC 标准的更新

2019年9月25日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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