Novel Coding Strategies for Children With Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Change in spectral resolution in Cochlear implant participants
研究概览
简要总结
The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory system. Information from individuals with and without cochlear implants will be compared.
详细描述
The overall objectives of this research are to 1) gain a better understanding of fundamental psychophysical abilities with electrical stimulation as a function of age (child vs adult), age at onset of deafness (pre- vs post-lingual), and acoustic hearing (normal vs limited or residual); and 2) determine whether manipulations in CI coding strategies will improve psychophysical and speech recognition outcomes for early implanted children. This work is expected to provide new insights into the corresponding improvements in perceptual outcomes to these newer strategies have been modest at best and performance has begun to level off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 7 years of age or older and pre-lingually implanted with a cochlear implant (before the age of 2 years), have aided residual hearing, or have normal hearing.
- •Be ages 18 or older and post-lingually implanted or have normal hearing.
- •Be ages 18-35 and pre-lingually implanted.
排除标准
- •Any child implanted post-lingually
研究组 & 干预措施
Early Adult Cochlear Implant (EarlyAdultCI)
Early implanted adults, ages 18 to 35 years
干预措施: Single-Electrode Pulse Train (Other)
Early Adult Cochlear Implant (EarlyAdultCI)
Early implanted adults, ages 18 to 35 years
干预措施: Sound coding strategy. (Other)
Late Adult Cochlear Implant (LateAdultCI)
Post-lingually implanted adults, 18+ years
干预措施: Single-Electrode Pulse Train (Other)
Late Adult Cochlear Implant (LateAdultCI)
Post-lingually implanted adults, 18+ years
干预措施: Modulation Detection Threshold (MDT) and Gap Detection Tasks (Other)
Late Adult Cochlear Implant (LateAdultCI)
Post-lingually implanted adults, 18+ years
干预措施: Sound coding strategy. (Other)
Early Child Cochlear Implant (EarlyChildCI)
Early implanted children, ages 7-17 years
干预措施: Modulation Detection Threshold (MDT) and Gap Detection Tasks (Other)
Early Child Cochlear Implant (EarlyChildCI)
Early implanted children, ages 7-17 years
干预措施: Sound coding strategy. (Other)
Early Child Cochlear Implant (EarlyChildCI)
Early implanted children, ages 7-17 years
干预措施: Electric-only spectral resolution (Other)
Cochlear Implant (CI)
CI children, ages 7-17 years, with aided residual hearing (bimodal/contralateral, electric+acoustic/ipsilateral)
干预措施: Electric-only spectral resolution (Other)
Normal Hearing Children (NHC)
Ages 7-17 years, Control Group
干预措施: Modulation Detection Threshold (MDT) and Gap Detection Tasks (Other)
Normal Hearing Adults (NHA)
18+ years, Control Group
干预措施: Modulation Detection Threshold (MDT) and Gap Detection Tasks (Other)
结局指标
主要结局
Change in spectral resolution in Cochlear implant participants
时间窗: Baseline Visit (Day 1) , Visit week 10
A one-way ANOVA will be used to calculate the differences between the four groups. If significant, post-hoc t-tests will be performed using Rom's modified Bonferroni Type I error correction.
Difference in performance between the reduced channel map and the full map
时间窗: Baseline Visit (Day 1) , Visit week 10
A mixed-design ANOVA will be conducted for each of the tests with subject population as the between-subjects factor and sound coding strategy as the within-subjects factor
Change in temporal resolution in Cochlear implant participants
时间窗: Baseline Visit (Day 1) , Visit week 10
A mixed-effect ANOVA will be conducted to determine if there is an effect of age group (children vs adults) and hearing condition (CI vs NH) for both modulation detection and gap detection tasks. Post-hoc two-sample t-tests will compare differences between NH and CI children as well as NH and CI adults. Post-hoc paired t-tests will compare differences between adults and children for both the NH and the CI populations.
Change in loudness growth in Cochlear Implant participants
时间窗: Baseline Visit (Day 1) , Visit week 10
Power functions will be fit for each of the loudness growth curves. Data will be analyzed using a mixed-design ANOVA with the two groups as the between-subjects factor and electrode and rate as within-subject factors.
次要结局
未报告次要终点