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临床试验/NCT03937388
NCT03937388已完成不适用

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

Angelica Perez Fornos1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Performance in standardized speech perception tests

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Cochlear implant recipients

Experimental

干预措施: Cochlear stimulation strategy including time-fixed gaps (Other)

结局指标

主要结局

Performance in standardized speech perception tests

时间窗: Day 1

Consonant and word recognition tests

次要结局

  • Comparison of volume levels resulting in equal loudness perception(Day 1)

研究者

发起方
Angelica Perez Fornos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Angelica Perez Fornos

Head of Engineering, Senior Lecturer

University Hospital, Geneva

研究点 (1)

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