Stimulating the Cochlear Apex Without Longer Electrodes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli
研究概览
简要总结
The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
- •They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
- •Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.
排除标准
- •They are under the age of 18
- •They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
- •Have >15 years of profound deafness
- •Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
- •Are pregnant or plan to conceive within 6 months of consenting
研究组 & 干预措施
Apical ground electrode
Participants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach.
干预措施: Modified surgical approach (Procedure)
Apical ground electrode
Participants in this group will have already received a cochlear implant using the new approach or be receiving a cochlear implant with the new approach.
干预措施: Cochlear Nucleus CI632 cochlear implant (Device)
Standard location ground electrode
Participants in this group have received a cochlear implant with the typical ground electrode placement.
干预措施: Cochlear Nucleus CI632 cochlear implant (Device)
结局指标
主要结局
Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli
时间窗: Month 12
The upper limit of rate pitch perception will be evaluated for Apex-monopolar (MP), 22-Apex, 22-MP, and 11-MP cochlear implant stimuli using a 3-up 1-down 2-interval forced-choice adaptive task. The task measures the highest modulation frequency perceived as a lower pitch compared to a rate 5 semitones higher. A series of 750-ms, 5000-pps pulse trains with 100% amplitude modulation will be presented at a loudness-balanced most-comfortable level. The upper limit will be estimated from the average modulation frequency of the last 6 reversals across 10 trials per stimulation site.
Mean pitch rank
时间窗: Month 12
Pitch-ranking will be done using a 2-interval forced-choice protocol in which the pitch of a newly selected stimulus is ranked relative to the stimulus in the middle of a pitch-rank order list. Depending on the ranked pitch direction, this stimulus is repositioned in the pitch-rank order list and ranked against a neighboring stimulus until the correct position in the list is determined. This process repeated until all stimuli are successfully pitch ranked. A complete set of pitch ranks are measured 10 times allowing for the calculation of a mean rank and 95% confidence interval for the rank of each interval.
Percentage of Consonant-Nucleus-Consonant (CNC) words correctly repeated
时间窗: Month 12
Speech perception will be assessed using CNC word lists, a common method for evaluating monosyllabic word recognition. The CNC Monosyllabic Word Test includes 10 lists of 50 words. The word test score range typically used is between 10% and 60% correct in the ear to be implanted, and equal to or better than that ear in the contralateral ear, but not better than 80% correct.
次要结局
未报告次要终点