Electric Pace-pitched Hearing Achieves Natural Tonotopy
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Speech understanding in quiet with cochlear implant
研究概览
简要总结
In search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (CI), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. At the moment, however, CI's are fitted with a 'one size fits all' principle. This is known to cause a mismatch between the frequencies presented by the CI electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. In this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. The natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of CI-recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adult (18y or older) and meeting the conventional Dutch CI criteria;
- •Proficient speaker of Dutch language;
- •Post-lingual onset of profound deafness (> 4 years of age);
- •Subject receives an Advanced Bionics implant with Midscala electrode and an Advanced Bionics sound processor;
- •Prepared to use study specific hearing aid (Phonak) for the duration of the study;
- •Rehabilitation at MUMC+ for the first year after surgery regarding CI as well as HA;
- •Active participation in trial related procedures such as daily randomization and regular testing.
排除标准
- •Physical or non-physical contraindications for MRI or CT imaging;
- •Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24;
- •Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon;
- •Active participation in another prospective clinical trial;
- •Pregnancy at time of imaging;
- •Requirement for electric-acoustic activation prior to the first year follow-up;
- •Having received a cochlear implant earlier (e.g. explantation or bilateral implantation).
研究组 & 干预措施
Imaged based fitting
Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.
干预措施: Imaged based fitting (Device)
Clinical routine
Mapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine.
结局指标
主要结局
Speech understanding in quiet with cochlear implant
时间窗: During the first 12 months of CI rehabilitation
Speech understanding with CI in quiet measured with the Dutch Consonant Nucleus Consonant (CNC) test.
Speech understanding in noise with cochlear implant
时间窗: During the first 12 months of CI rehabilitation
Speech understanding with CI in noise will be measured with the Dutch Matrix sentence test.
Patient preference
时间窗: During the first 12 months of CI rehabilitation
At every fitting session, patients will be asked to rate their satisfaction with either the control or experimental program on a 10-point Visual Analog Sscale (1 dissatisfied - 10 very satisfied).
次要结局
- Speech understanding with hearing aid(During the first 12 months of CI rehabilitation)
- Listening effort(During the first 12 months of CI rehabilitation)
- Spatial masking(During the first 12 months of CI rehabilitation)
- Overall Quality of life(During the first 12 months of CI rehabilitation)
- Spectral resolution (SMRT test)(During the first 12 months of CI rehabilitation)
- Quality of life in relation to hearing ability.(During the first 12 months of CI rehabilitation)
- Loudness scaling (ACALOS test)(During the first 12 months of CI rehabilitation)
- Telemetric data(During the first 12 months of CI rehabilitation)
- Overall wellbeing(During the first 12 months of CI rehabilitation)