Aural Rehab for Adult CI Outcomes
A Phase I, Single-Center Study of the Effects of Aural Rehabilitation Protocols on Adult Cochlear Implant Outcomes
This study will compare two different types of aural rehabilitation schedules (computer-based auditory training vs computer based auditory training and clinician guided training) for adult cochlear implant (CI) users to determine the effect of rehabilitation type on speech perception, hearing related-quality of life, and CI management skills.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：J. Thomas Roland, Jr., MD
- 电话号码：212-263-5565
- 邮箱：J.Thomas.RolandJr@nyulangone.org
学习地点
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New York
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New York、New York、美国、10016
- NYU Langone Heath
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Be at least 18 years of age at the time of cochlear implantation.
- Receive pre- and post-CI care at the NYU Langone Health Cochlear Implant Center.
- Have bilateral hearing loss, with at least moderate to profound hearing loss in both ears.
- Be able to participate in follow-up visits, either in person or via synchronous telehealth, and to use an app-based training platform (ReDi).
- Be English-speaking or have native-like English proficiency.
Exclusion Criteria:
- Has significant cognitive impairment or a medical disability that precludes informed consent or reliable participation or develops such impairment during the study period.
- Has pre-lingual or long-term (>20 years) severe to profound hearing loss
- Is undergoing cochlear implantation for single-sided deafness.
- Is undergoing revision CI surgery.
- Is younger than 18 years of age.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Computer-Based Auditory Training
CI users assigned to receive computer-based auditory training only. |
Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation. |
|
实验性的：Computer-Based Auditory Training + Clinician-Guided Training
CI users assigned to receive computer-based auditory training and clinician-guided training. |
Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation. Aural rehabilitation program delivered by a speech-language pathologist. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in CNC Word Recognition Score
大体时间：Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Calculated as the percentage of words a person can hear, repeat back, and understand. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
|
Change in CNC Phoneme Recognition Score
大体时间：Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Calculated as the percentage of individual phonemes (sounds) identified correctly out of 150 total phonemes. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
|
Change in AzBio Sentence Recognition Score
大体时间：Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Standardized speech perception assessment used by audiologists to measure how well a person understands everyday conversational speech. Patients are evaluated on their ability to recognize words correctly in a sentence. Each sentence has a set number of key words assigned specific point values. The final score is calculated as a percentage of words correct out of the total possible words in the list. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in CIQOL35 Profile Score
大体时间：Week 6 Post-Activation, Year 1 Post-Activation
|
Patient-reported outcome measure designed to evaluate real-world functional abilities and quality of life for adult cochlear implant (CI) users. Each item is rated on a Likert scale; the raw score is re-scaled into a total score from 0 (low quality of life/functional ability) to 100 (high quality of life/functional ability). |
Week 6 Post-Activation, Year 1 Post-Activation
|
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Change in CIMS-Self
大体时间：Week 6 Post-Activation, Year 1 Post-Activation
|
10-item self-administered assessment of how effectively a patient or caregiver handles and maintains a cochlear implant processor. Each response is rated from 0 to 3; the raw score is the sum of responses and is transformed to a percentage (0 - 100%); a score below 100% indicates a need for targeted training or retraining in specific maintenance areas. |
Week 6 Post-Activation, Year 1 Post-Activation
|
合作者和调查者
调查人员
- 首席研究员：J. Thomas Roland, Jr., MD、NYU Langone Health
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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