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临床试验/NCT03685461
NCT03685461已完成不适用

AB-Intra- and Post-Operative Measures of Auditory Function

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Harris

Associate Professor

Medical College of Wisconsin

研究点 (1)

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