O15-PET Imaging of Cochlear Implant Speech in Noise Processing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To identify the cortical bases for speech-in-noise understanding in cochlear implant users
研究概览
简要总结
The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.
详细描述
Despite the success of a cochlear implant (CI) for providing or improving hearing ability for people with severe hearing loss, everyday conversations in background noise are still the main clinical complaint. The goal of this study is to understand the neural mechanisms by which listeners with a CI detect speech in noisy environments, and to understand how these mechanisms differ across a variety of CI listeners, in order to determine what variables are most relevant for predicting successful outcome. Therefore the purpose of PET neuroimaging in this study is to find the brain regions that relate to speech in noise effort using PET during auditory stimulation on a single session across a variety of CI users with different device configurations. An age-matched typical hearing control group provides a baseline for comparison. PET neuroimaging will be performed using a radioactive form of water, O-15 (an investigational agent), that will be injected into the body to examine brain blood flow using a PET/CT scanner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cochlear Implant subjects (enrollment is planned at N=120) - Inclusion criteria:
- •Between 18 and 99 years of age.
- •Have a cochlear implant activated for more than one year.
- •Eligible for research under the Iowa Cochlear Implant Project VIII.
- •Ability to understand and willingness to sign a written informed consent document.
- •Severe hearing loss after age
- •Normal Hearing subjects (enrollment is planned at N=30) - Inclusion criteria:
- •Between 18 and 99 years of age.
- •Have age typical hearing.
- •Eligible for research under the Iowa Cochlear Implant Project VIII.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •(all groups):
- •Medical history includes seizure disorder, head injury, neurologic, metabolic, cardiovascular disease, or previous cerebrovascular event (unless approved by PI).
- •Female self-reporting pregnancy. A urine pregnancy test will be performed prior to injection of the radiopharmaceutical.
- •Currently taking medications which may affect cerebral blood flow (e.g., papaverine, ginkgo biloba, acetazolamide).
- •Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.
研究组 & 干预措施
Cochlear implant
Experienced (greater than 1 year) cochlear implant recipients
干预措施: Cochlear implant (Device)
Age-typical hearing control
Age-matched, age-typical (normal) hearing control participants
结局指标
主要结局
To identify the cortical bases for speech-in-noise understanding in cochlear implant users
时间窗: Basline Visit
PET imaging will be used to identify the brain regions for listeners ability to recognize speech in noise at different signal-to-noise ratios.
次要结局
未报告次要终点
研究者
Craig D. Workman, PhD
Principal Investigator
University of Iowa