Study of Auditory Performance on Postoperative Prosodic Tests in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy. Prospective Longitudinal Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Prosodic test
研究概览
简要总结
Main objective:
Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech
Secondary objectives:
Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results
详细描述
Introduction:
Prosodie is the study of the phenomena of accentuation and intonation (variation of pitch, duration and intensity) allowing the conveyance of information related to the sense such as the relief, but also the assertion, interrogation, injunction, exclamation ...
It has a role at the grammatical, emotional and pragmatic levels of communication by informing about the emotional state of the speaker (sad / happy), about sex and identity, about the type of statement (question / affirmation) and about the borders in the sentences.
The auditory cues that play a role in the perception of prosody include changes in the fundamental frequency F0 (ie vibrational frequency of the speaker's vocal cords) during a speech, the duration of the syllables, or the rate or intensity of the speech. [Di Christo 2013] The cochlear implant is a device for auditory rehabilitation. Its principle is to transform the analog signals recorded by a microphone into digital signals that directly stimulate the fibers of the auditory nerve through electrodes inserted into the cochlea. [HAS 2012, HAS 2007, http://www.has-sante.fr\] Cochlear implants are indicated in cases of severe or profound sensorineural deafness.
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. [Wilson & Dorman 2008] The pitch is only partially transmitted by these conventional strategies [Moore 2003; Oxenham 2008] which would explain the poor results of cochlear implants in the perception of music [Bruns & al. 2016; Galvin III & al. 2009; Veekmans & al. 2009; Cooper & al. 2008] and prosody [Kalathottukaren & al. 2015 ; Meister et al. 2011; Meister et al. 2009].
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
- •Patient with MED-EL cochlear implant (Sonnet / Synchrony)
- •Adult patient (≥ 18 years old) speaking French
- •Patient having an estimate of the optimal size of the electrode for its cochlea with the MED-EL software before their implantation.
- •Patient with post-implant audiometry thresholds without cochlear implant > 80 dB HL on 250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing)
- •Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6 months post-activation
排除标准
- •Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
结局指标
主要结局
Prosodic test
时间窗: at 12 month post-activation
Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24
次要结局
- Prosodic test(at 6 month post-activation)
- Differential frequency threshold(at 12 month post-activation)
- Vocal audiometry in quiet and noise(at 12 month post-activation)