NCT00784043终止不适用
Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 18
- 主要终点
- Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
研究概览
简要总结
The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.
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
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 12 and 36 months of age at time of implantation
- •Profound bilateral sensorineural hearing loss
- •English as the primary language in the home
- •Realistic expectations of guardians
- •Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
- •Willing and available to comply with all scheduled procedures as defined in the protocol
- •Audiological:
- •Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification
- •Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
- •Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.
- •All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.
- •Good general health status, as judged by Primary Investigator
- •Patent cochleae bilaterally, as indicated by radiological evaluation
- •No contraindications for surgery, in general, or cochlear implant surgery in particular
排除标准
- •Prior experience with any cochlear implant system
- •Younger than 12 months or older than 36 months at time of implantation
- •Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy
- •Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation
- •Abnormal or malformed cochlea(e) to be implanted
- •Severed or non-functional auditory nerve in the ear(s) to be implanted
- •Central auditory lesion
- •Cognitive and/or neurological dysfunction
- •Auditory neuropathy
研究组 & 干预措施
Bilateral
Experimental
Bilaterally implanted simultaneously
干预措施: Cochlear Implant (Device)
Unilateral
Experimental
Unilaterally implanted
干预措施: Cochlear Implant (Device)
结局指标
主要结局
Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
时间窗: 60 months post initial stimulation
Speech perception scores will be compared pre-operatively and postoperatively.
次要结局
- Language Acquisition Over Time in Bilaterally Implanted Children.(60 months post initial activation)
- Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.(5 years)
研究者
研究点 (18)
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