A Feasibility, Prospective, Repeated-measures Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients: A Master Umbrella Investigation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Cochlear
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
研究概览
简要总结
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Investigational sound coding strategy and default sound coding comparator is blinded to the 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
- •Users of an approved Nucleus cochlear implant.
- •Aged 18 years or older (no upper age limit).
- •Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
- •Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- •Willing and able to provide written informed consent.
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
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
研究组 & 干预措施
Investigational sound coding strategy/Default sound coding strategy (Sub A)
Tested with investigational and default sound coding strategies
干预措施: Investigational sound coding strategy (Device)
Investigational sound coding strategy/Default sound coding strategy (Sub A)
Tested with investigational and default sound coding strategies
干预措施: Cochlear default sound coding strategy (Device)
结局指标
主要结局
Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
时间窗: 0 to 12 weeks
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN) with speech presented at 65 dB SPL in adaptive 4-talker babble noise, both presented in front of the listener. It is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome.
次要结局
未报告次要终点