Study of Musical Perception and Post-operative Auditory Performance as a Function of the Depth of Stimulation in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy Single-center Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Qualitative measure of music with direct audio link
研究概览
简要总结
Main objective:
Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater.
Secondary objectives:
Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.
详细描述
Introduction:
Conventional stimulation strategies in cochlear implants (e.g. ACE, CIS) use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes. The stimulation rate of the electrodes is constant.
The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music.
In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally.
Rader & al. 2016 have studied the contribution of adding to the tonotopic coding of the frequency (classical strategy) a temporal coding of the information by varying the stimulation rate. The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch (of normal-hearing) and less variability, especially at low frequencies. With fixed stimulation rate (classical strategy) low frequencies are poorly coded, whereas with the variable stimulation rate they are better coded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind study: the patient and the investigator don't know the strategy
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
- •Adult patient (≥ 18 years old) speaking French
- •Patient who fulfils the criteria for cochlear implantation
- •Patient with a postoperative insertion angle of the apical electrode > 450°
- •Patient with 12 active electrodes on the day of activation.
排除标准
- •Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
结局指标
主要结局
Qualitative measure of music with direct audio link
时间窗: at 2 months post-activation
The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sounds, loudness. Visual analog scales (VAS) are used for each dimension and the patient has to score the dimension on a 10 cm VAS (between 0 to 10). The test is performed with a direct audio link to the CI.
次要结局
- Qualitative measure of music(at 2 months post-activation)
- Speech recognition in quiet(at 2 months post-activation)
- Differential frequency threshold(at 2 months post-activation)
- Sound quality(at 2 months post-activation)