Anatomy-based Fitting in Unexperienced Cochlear Implant Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Word recognition score (WRS)
研究概览
简要总结
The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded design: both the participant and the investigator have no information about the treatment group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- •Post-OP CT scan of the CI electrode available
- •Subject implanted with MED-EL cochlear implant(s)
- •Subjects received a Flex28, FlexSoft and Standard electrode
- •Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
- •Audio processor not yet activated on the newly implanted side
- •The most apical active electrode contact has to be inserted at least 450°
- •Minimum of 10 active channels can be activated
- •Fluent in the language of the test centre
- •Signed and dated ICF before the start of any study-specific procedure
排除标准
- •Lack of compliance with any inclusion criteria
- •EAS user (user of an EAS audio processor)
- •Implanted with C40+, C40X and C40C
- •Implanted with an ABI or Split electrode array
- •Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
研究组 & 干预措施
Anatomy based fitting
干预措施: frequency distribution type (Other)
Standard fitting
干预措施: frequency distribution type (Other)
结局指标
主要结局
Word recognition score (WRS)
时间窗: 6 months
Percentage of correctly understood monosyllabic words from a list.
次要结局
- Speech reception threshold (SRT)(6 months)
- Pitch ranking(6 months)
- Perception of timbre(6 months)
- Phoneme categorization(6 months)
- Consonance/difference rating(6 months)
研究者
Dominik Riss
Assoc.-Prof. Priv.-Doz. Dr. med.
Medical University of Vienna