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临床试验/NCT06734897
NCT06734897招募中不适用

Impact of Music Therapy on Speech Intelligibility in Noise With Cochlear Implants

Armina Kreuzer2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Speech recognition threshold (SRT50) six month after Cochlear Implantation

研究概览

简要总结

The aim of this clinical study is to investigate whether six months of music therapy immediately after CI implantation helps to improve speech intelligibility in noise. To investigate the effect of music therapy, a randomized study will be conducted with a "start group A" and a "delayed group" B (control group 1). Group A will start six months of music therapy immediately after cochlear implantation, group B six months later. A further control group 2 will not receive any music therapy. The speech intelligibility values resulting from the OLSA sentence test will be compared between the three groups after six and twelve months.

详细描述

Improved speech perception is a main objective for any hearing rehabilitation using hearing devices. Even more challenging is speech comprehension in noisy environments.

Music therapy is one of the approaches that can assist users with achieving better performance in situations of difficult listening comprehension such as speech perception in noisy environments. One such music therapy concept developed in Heidelberg is based on the parallelism of language and music, whereby targeted training using musical parameters such as rhythm, pitch and timbre can have an impact on the ability to perceive speech. At present, the fact that music therapy can help improve speech intelligibility is primarily based on research with normal hearing listeners.

Nowadays, cochlear implant technology has the primary goal to restore functional hearing and speech perception in people with bilateral severe-to-profound sensorineural hearing loss. Good results will be achieved by post lingually deafened CI users regarding the understanding of open-set sentences presented in quiet. But our surroundings are rarely quiet. Therefore, the goal of good rehabilitation must be to ensure that CI users also can cope well in our noisy environment. Music therapy is thus intended to be the crucial piece in the puzzle that enables such understanding in noisy situations.

This study aims to investigate the benefits of music therapy for cochlear implant users in terms of their speech intelligibility performance in noise. This is an explorative study to determine suitable parameters such as the time point of starting the music.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged between 18-85 years
  • Patients who undergo a new CI Implantation
  • Patients who speak German as their main language

排除标准

  • 1. Patients with congenital deafness

结局指标

主要结局

Speech recognition threshold (SRT50) six month after Cochlear Implantation

时间窗: six month after Cochlear Implantation

The variable of primary interest is the speech recognition threshold (SRT50), measured in dB SNR (Signal-to-Noise Ratio), which leads to 50% speech understanding, as obtained using the OLSA-test following six months of music therapy immediately after implantation.

次要结局

  • values of SRT50 of group A and B at twelve months(twelve months)
  • Values of SRT50 of all groups at 12 months(12 months)
  • subjective improvements of speech intelligibilty(6 and 12 months)

研究者

发起方
Armina Kreuzer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Armina Kreuzer

Dr. tech.

Luzerner Kantonsspital

研究点 (2)

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