A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Monosyllabic Word in Quiet Scores.
研究概览
简要总结
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.
Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.
Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.
A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.
The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding.
- •Paediatrics: Older than 5 years and <18 years when entering the study. (Belgium only) or
- •Adults: ≥18 years when entering the study (Belgium and Australia).
- •Subject/legally designated representative is fluent speaker in the language used for assessments.
- •Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative).
排除标准
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- •Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- •Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- •Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
研究组 & 干预措施
All Participants
Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
干预措施: SPACE (Device)
All Participants
Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
干预措施: OPAL-SPACE (Device)
All Participants
Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
干预措施: ACE (Device)
All Participants
Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
干预措施: Cochlear Device Interface (CDI) Tool (Device)
结局指标
主要结局
Monosyllabic Word in Quiet Scores.
时间窗: One Day
Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome
次要结局
未报告次要终点