A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cochlear
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Australian Sentence Test in Noise (AuSTIN)
研究概览
简要总结
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
详细描述
This is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. The Master Umbrella design will enable the execution of a series of sub-investigations in the same user population, with the goal to evaluate a range of speech enhancement pre-processing algorithms in separate sub-investigations. The primary objectives for each sub-investigation will be consistent with the master umbrella investigation, with secondary and exploratory objectives selected based on the algorithm to be investigated. Secondary and exploratory objectives will be described in the sub-investigation documentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Order of IMD and comparator is blinded.
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
- •User of an approved Nucleus cochlear implant.
- •User of the ACE (Advanced Combination Encoder) sound processing strategy.
- •Aged 18 years or older (no upper age limit).
- •Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.*
- •Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- •Willing and able to provide written informed consent.
- •≥3 months post cochlear implant activation
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 the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees or employees of Contract Research Organizations 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 Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E)
干预措施: Investigational Pre-Processing Algorithm (Sub E) (Device)
Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E)
干预措施: Cochlear Limited standard-of-care pre-processing algorithms (Device)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)
干预措施: Investigational Pre-Processing Algorithm (Sub A) (Device)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)
干预措施: Cochlear Limited standard-of-care pre-processing algorithms (Device)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)
干预措施: Cochlear Limited standard-of-care pre-processing algorithms (Device)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)
干预措施: Investigational Pre-Processing Algorithm (Sub B) (Device)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)
干预措施: Investigational pre-processing algorithm (Sub D) (Device)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)
干预措施: Cochlear Limited standard-of-care pre-processing algorithms (Device)
Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)
干预措施: Cochlear Limited standard-of-care pre-processing algorithms (Device)
Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)
干预措施: Investigational Pre-Processing Algorithm (Sub C) (Device)
结局指标
主要结局
Australian Sentence Test in Noise (AuSTIN)
时间窗: 1 day - Immediately post-screening
To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores. Scoring: AuSTIN 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