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临床试验/NCT06128161
NCT06128161已完成不适用

Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
PEPS-C speech test battery

研究概览

简要总结

An observational study to determine and assess perception of prosodic information in adults who use bimodal stimulation (cochlear implant plus hearing aid) when using both devices vs. cochlear implant alone.

详细描述

People with severe to profound hearing loss often do not get satisfactory benefit from their hearing aids. A cochlear implant (CI) is a prosthetic device for the inner ear which can directly stimulate the auditory nerve, bypassing damaged inner ear hair cells and thus provide audible sensations to profoundly deaf patients.

Currently, one CI is funded by NHS England for adult patients and the eligibility criteria for implantation has been relaxed in recent years. As a result, there are now an increasing number of unilateral CI users who possess low-frequency residual hearing in their non-implanted ear. For many patients this residual hearing may still be usefully amplified by a HA. This configuration, consisting of a CI and a contralateral HA, is known as bimodal stimulation.

The PEPS-C receptive test battery has been previously used to assess prosody perception in hearing loss.

The current project will use selected tests from the PEPS-C prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and CI alone.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Has unilateral Cochlear Implant
  • Consistent use of Hearing Aid
  • Obtains some benefit in speech discrimination from hearing aid (> 20% AB words)
  • Post-lingually deafened
  • Fluent English

排除标准

  • Longstanding significant asymmetry (> 20 dB HL 4 frequency average) in hearing where the unimplanted ear is the worse ear
  • Inconsistent Hearing Aid use
  • Significant conductive hearing loss (> 20 dB HL 4 frequency average)
  • Using Electro-Acoustic stimulation Cochlear Implant
  • Aetiology of hearing loss likely associated with auditory neuropathy
  • Significantly abnormal appearance of cochlea or cochlear nerve

结局指标

主要结局

PEPS-C speech test battery

时间窗: Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions

Test battery of 7 speech tests examining prosodic elements of speech, each section scored out of 16 (112 in total higher scores better outcome)

次要结局

  • AB words speech test(Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions)
  • SSQ12 Questionnaire(Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions)
  • BKB sentences speech test(Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions)
  • Unaided Soundfield Audiometry(Tested at one time point at day 1 of study after recruitment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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