Multi Center Clinical Study to Assess the Safety of the UTD Cochlear Implant PDA (ciPDA) REsearch Platform
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The objective of this study is to assess the safety of the PDA device after long-term use. Safety shall be measured by the adverse events reported in this study and compared to the study results reported in the clinical study for the PMA'd device.
研究概览
简要总结
The primary purpose of the research is to study how individuals who wear cochlear implants process sounds in noisy environments and also whether newly designed programs can help improve the communicative ability of cochlear implant patients in noisy situations.
详细描述
Cochlear implants have been successful in restoring partial hearing to profoundly deaf people. Despite their success, most implant patients are not able to communicate in noisy environments (e.g., in a restaurant). Communicating in noise still remains one of the biggest challenges in cochlear implants. Little is known about the factors that contribute to the poor performance of CI users in noise. In this project, we propose a series of experiments aimed at isolating these factors. We propose new programs that can be tailored for noisy situations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Post-lingually deafened adults:
- •18 years of age or older
- •Unilateral or bilateral Nucleus implant users (this includes all three generations of the Nucleus system, i.e., CI22, CI24 and CI24R).
- •With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant.
- •A minimum test score of 30% in tape-recorded open-set sentence recognition scores (e.g., spondee identification).
- •Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant.
- •Minimum number of active electrodes: 10
- •Minimum number of subjects for each test site: 5
- •Prelingually and perilingually deafened adults:
- •18 years of age or older
- •Unilateral or bilateral Nucleus implant users.
- •With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant.
- •A minimum test score of 10% in tape-recorded open-set sentence recognition scores (e.g., spondee identification).
- •Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant.
- •Minimum number of active electrodes: 10
- •Minimum number of subjects for each test site: 5
排除标准
- •Non-English speaking
- •Hearing loss of neural or central origin
- •Absence of cochlear or VIII nerve development
- •The presence of systemic condition which would preclude use of a cochlear implant
- •Active middle ear infection/tympanic membrane perforation
- •Significantly abnormal cognitive function, as determined by case history information and/or clinical observations
- •Significant psychiatric disorder, as determined by case history information and/or clinical observations
结局指标
主要结局
The objective of this study is to assess the safety of the PDA device after long-term use. Safety shall be measured by the adverse events reported in this study and compared to the study results reported in the clinical study for the PMA'd device.
时间窗: 5 weeks
次要结局
未报告次要终点
研究者
Philip Loizou
PI
The University of Texas at Dallas