AB-Intra- and Post-Operative Measures of Auditory Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The CI electrode's scalar position as indicated by post-operative computed tomography (CT)
研究概览
简要总结
The purpose of this study is to see how the inner ear responds to sound delivered to the ear canal during and after your cochlear implant surgery. This information may be helpful in telling us how well a cochlear implant performs after surgery.
详细描述
Background and Objectives of the Study
Cochlear Implantation A cochlear implant (CI) is a prosthetic device for the inner ear that bypasses damaged inner ear hair cells and directly stimulates the auditory nerve, thereby providing audible sensations to patients with sensorineural hearing loss (SNHL). The implanted part consists of a hermetically sealed electronics package, a receiver coil which communicates with external components, and a magnet to help align the internal and external receiver coils. Attached to the implant package is the lead assembly that includes an array of electrode contacts that is inserted into the cochlea and interacts with its stimulable elements, the spiral ganglion cells and the cochlear hair cells. Today's CI models have between 12 and 22 intra-cochlear electrode contacts, each of which can be independently stimulated. In the healthy cochlea, different pitches are perceived at distinct locations along the length of the cochlea. This tono-topic organization is utilized when stimulating the cochlea electrically, as individual contacts can preferentially address neural populations associated with discrete regions of the cochlea. For example, when a low-pitched sound is captured by the microphone of the external sound processor, stimulation is routed to more apical electrodes, while for high-pitched sounds more basal electrode contacts are engaged.
Performance and Candidacy
Cochlear implants are currently the standard-of-care for patients with significant SNHL and poor speech understanding. Preservation of the delicate anatomy within the cochlea is well-known to correlate with hearing and speech understanding outcomes. During electrode insertion, it is common for the surgeon to make subtle adjustments to insertion parameters such as the angle of insertion or speed of insertion; such modifications are part of the standard-of-care of conventional CI surgery. The current state of conventional CI electrode insertion provides the surgeon with no feedback as to whether and when the delicate structures of the cochlea are damaged. Such a tool by which the surgeon can obtain real-time measurements of the electrophysiological function of the cochlea could help improve the current surgical procedure.
Electrocochleography
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
participant blinded to condition surgeon aware by necessity data reviewers blinded
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pure-tone audiometry thresholds ≤80 dB HL at 500 Hz
- •One year of age and older
- •Normal candidacy requirements for cochlear implantation met
- •No cochlear abnormality that might prevent full insertion of the CI electrode array
- •No additional handicap that would prevent study procedures from being followed
排除标准
- •Chronic otitis media
- •Malformed cochlea
- •Auditory neuropathy spectrum disorder (ANSD)
- •Presence of ear tubes
- •Prior middle ear surgeries or trauma including disruption of ossicles
研究组 & 干预措施
Arm 1: Audible ECochG Response Off
Arm 1: Audible ECochG Response Off This condition is identical to the current standard-of-care for conventional CI surgery used worldwide. The surgeon will perform his or her electrode insertion without ECochG monitoring. Minute manipulations of the electrode are a normal part of conventional electrode insertion; manipulations such as redirecting the insertion vector or slowing down insertion speed will be made, as deemed necessary by the surgeon. A full electrode insertion will be performed, as appropriate. The ECochG responses will be recorded, but the surgeon will be blinded to this information during surgery.
干预措施: Electrocochleography (Other)
Arm 2: Audible ECochG Response On
This condition will have the audible ECochG response on and available to the surgeon. In this condition, the surgeon perform a conventional electrode insertion while listening to the running ECochG signal for drop in amplitude (suggesting impending trauma). If no drop is detected, insertion will proceed to the full electrode length according to the standard-of-care. If an ECochG amplitude drop is observed, the surgeon will place this observation in its clinical context and evaluate insertion parameters, (i.e., insertion vector, insertion speed, etc.), customary practice with conventional CI surgery, but here supplemented by the ECochG response. In the case of an ECochG amplitude drop that does not recover, the standard-of-care practice of achieving a full electrode insertion will be followed.
干预措施: Electrocochleography (Other)
结局指标
主要结局
The CI electrode's scalar position as indicated by post-operative computed tomography (CT)
时间窗: To be performed within one month of cochlear implantation
Following cochlear implant surgery a CT scan, optimized for resolution of the CI electrode, will be obtained. This will be merged with routine clinically acquired pre-operative imaging to determine which of the scala the electrode sides in and whether or not there has been any translocation from one scala into another.
次要结局
- Post-operative hearing performance(To be collected at post-op clinical visits until 12 months post-op)
研究者
Michael Harris
Associate Professor
Medical College of Wisconsin