Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
赞助:
Med-El Elektromedizinische Geraete GmbH
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 26, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Prosodic test[ Time Frame: 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 |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy | ||
| 正式标题 ICMJE | 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 | ||
| 简要概况 | 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 |
||
| 详细说明 | 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]. 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. The FineHearing coding strategy of MED-EL with long insertion of electrode could therefore make it possible to better transmit the prosody and specifically to better extract the fundamental frequency F0 of the voice. Objective of the study The objective of the study is to evaluate if the FineHearing strategy of the MED-EL implant allows to better transmit the prosody and specifically by the fundamental frequency of the voice (F0). Main objective: Show that the MED-EL FineHearing strategy (with deep insertion of the electrode) allows to extract prosody cues based only on the fundamental frequency F0. Secondary objectives: - evaluate differential frequency thresholds and correlation with prosodic performance - Evaluate the positioning of the electrode array and its effect on prosodic performance Plan of study: It is a prospective open multicenter longitudinal study: measures will be done on the patient at 6 and 12 month post-activation. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Other |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 1, 2020 | ||
| 预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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 Exclusion criteria: - Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Med-El Elektromedizinische Geraete GmbH | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号