Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Changes in phoneme discrimination scores
研究概览
简要总结
Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria
- •Adult at least 18 years old
- •Native speakers of American English
- •Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
- •CHILDREN Inclusion Criteria
- •Children at least 3 months old
- •Native speakers of American English
- •Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
- •For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.
排除标准
- •Exclusion for all Cochlear Implant Subjects:
- •Inability to provide informed consent
- •Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device
- •Unable to carry out the study protocol or tasks required in the study
- •Exclusion for all Normal Hearing Subjects:
- •Inability to provide informed consent
- •Hearing loss, or significant history of hearing related issues
- •Unable to carry out the study protocol or tasks required in the study
研究组 & 干预措施
Performance Assessed with Experimental Sound Processing Strategy
Patients listening to experimental cochlear implant processing strategy.
干预措施: Experimental Speech Processing Strategy (Other)
Control
Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
Experimental Control
Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.
干预措施: Experimental Speech Processing Strategy (Other)
结局指标
主要结局
Changes in phoneme discrimination scores
时间窗: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.
Changes in time (weeks) with programming strategy
时间窗: Baseline and weekly for 10 weeks after the intervention
Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.
Slopes of the spread of excitation of the electrically evoked compound action potential responses
时间窗: Baseline
Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.
Changes in speech-gap detection thresholds
时间窗: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.
Changes in vowel identification scores
时间窗: Baseline and weekly for 10 weeks after the intervention
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Changes in sentence recognition scores
时间窗: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
时间窗: Baseline
A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.
次要结局
- Age(Age at baseline)
- Macarthur-Bates vocabulary inventory scores(Baseline, and weekly for 10 weeks after the intervention)
- Sound quality questionnaire(Baseline and weekly for 10 weeks after the intervention)
- Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores(Baseline, and weekly for 10 weeks after the intervention)
- Hearing quality of life (HEARQL) scores(Baseline, 5 weeks, and 10 weeks after the intervention)
研究者
Julie G. Arenberg, CCC-A
Director of Research and Education
Massachusetts Eye and Ear Infirmary