比较基于分类响度缩放的拟合与行为拟合在激活后 3 个月内使用 Nucleus 人工耳蜗的成人的性能 (CALOS4)
可行性、前瞻性、受试者内、干预性研究，比较基于分类响度缩放的拟合与行为拟合在激活后前 3 个月内使用 Nucleus 人工耳蜗的成人的性能
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 年满 18 岁（无年龄上限）。
- 语言后耳聋定义为根据受试者报告的 2 岁后严重或更严重的感音神经性听力损失发作
- 单侧植入CI600系列（CI612、CI622、CI632）或CI500系列（CI512、CI522、CI532）人工耳蜗。
- 由研究者确定，能够流利地使用用于评估言语感知能力的语言。
- 愿意参与并遵守协议的所有要求。
- 愿意并能够提供书面知情同意书
排除标准：
- 在移动设备熟练程度调查问卷的筛选问题子集上得分低于 3 分。
- 将在植入的耳朵中使用声学组件进行编程的对象。
- 纯音平均值（0.5、1、2 和 4 kHz 的独立阈值的平均值）小于或等于 30 dB HL，并且对侧耳的辅助单词得分超过 80%。
- 听神经病的诊断。
- 调查员已知的其他健康因素会阻止或限制参与评估，包括严重的视力障碍和/或灵活性问题。
- 不能或不愿意遵守研究者确定的临床研究要求。
- 与本研究直接相关的调查员现场人员和/或其直系亲属：直系亲属定义为配偶、父母、子女或兄弟姐妹。
- 科利耳员工或合同研究组织的员工或科利耳为本次调查聘用的承包商。
- 当前参与或在过去 30 天内参与另一项介入性临床研究/试验，涉及试验性药物或设备（除非另一项调查是科利耳赞助的调查，并且由研究者或赞助商确定不会影响该调查）。 -
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：接受基于分类响度缩放的拟合和行为拟合的参与者。
参与者将获得基于分类响度缩放的拟合（介入）和行为拟合，并具有 4 周的 MAPS 经验
|
比较器是使用 Custom Sound Suite (CSS 6.3) 软件的市售拟合方法（即活动通道的行为测量）
The research fitting system is used in combination with other devices as part of a hearing implant system.
It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system.
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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 Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
大体时间：At visit 4 (week 8) and visit 5 (week 12)
|
To determine whether the loudness target (LT) map provides non-inferior speech understanding in quiet compared to the behavioural map. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. The higher the score, the better the outcome. |
At visit 4 (week 8) and visit 5 (week 12)
|
|
Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
大体时间：At visit 4 (week 8) and visit 5 (week 12)
|
To determine whether the loudness target (LT) map provides non-inferior speech understanding in noise compared to the behavioural map.
Adaptive sentence in noise scores (S0N0 test setup) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB).
|
At visit 4 (week 8) and visit 5 (week 12)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
大体时间：At visit 4 (week 8) and visit 5 (week 12)
|
To determine whether the loudness target map provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the behavioural map. The SSQ12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into 3 sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The average SSQ12 scores (on entire questionnaire) for each map type were used. SSQ12 ratings were collected at visit 4 and visit 5. The change between LT to behavioural map is then calculated and the theoretical score could vary between -10 to + 10. The higher the score, the better the benefit. A positive score indicates improved hearing, while a negative value indicates impaired hearing. |
At visit 4 (week 8) and visit 5 (week 12)
|
|
Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
大体时间：Visit 3 (week 4)
|
To determine whether the LT map provides non-inferior speech understanding in quiet compared to the behavioural map early post activation.
|
Visit 3 (week 4)
|
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Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
大体时间：Visit 3 (week 4)
|
To determine whether the LT map provides non-inferior speech understanding in noise compared to the behavioural map early post activation.
Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50).
The SRT is determined at the end of the test.
A higher SRT means a worse outcome
|
Visit 3 (week 4)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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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