Effects of Noise Exposure and Near Infrared Light (NIL) on Auditory Health and Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Change in auditory threshold
研究概览
简要总结
The primary objective of this work is to determine the effect noise has on the auditory system (both auditory health and performance) and also the degree to which the effect of pre-noise therapy such as Near Infrared (NIR) light can mitigate the effects of noise exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years old, male or female
- •Pass hearing exam with a threshold of 25 decibels (dB) hearing or less, for each ear, for all frequencies tested from 500 Hz to 8000 Hz
- •Normal otoscopic exam, otoacoustic emissions (OAEs), and middle ear function as demonstrated by a normal tympanogram
- •Completion of a hearing history questionnaire
排除标准
- •Screening hearing test failure
- •Pregnant females
- •Adults unable to provide consent
- •History of significant ear surgery
研究组 & 干预措施
Noise Stimulus and Infrared Light
All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive infrared light therapy for 2 out of the 4 visits and sham infrared light therapy for the other 2 visits.
干预措施: Near Infrared Light (Device)
Noise Stimulus and Infrared Light
All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive infrared light therapy for 2 out of the 4 visits and sham infrared light therapy for the other 2 visits.
干预措施: Noise Stimulus (Other)
Noise Stimulus and Sham
All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive sham infrared light therapy for 2 out of the 4 visits and infrared light therapy for the other 2 visits.
干预措施: Noise Stimulus (Other)
Noise Stimulus and Sham
All participants will receive noise stimulus at each of the 4 visits. In addition, they will receive sham infrared light therapy for 2 out of the 4 visits and infrared light therapy for the other 2 visits.
干预措施: Sham Near Infrared Light (Device)
结局指标
主要结局
Change in auditory threshold
时间窗: Baseline, up to 365 days
Auditory function tests will be measured through the change in air conduction threshold measurements from 500 up to 8000 Hz
次要结局
- Change in central auditory performance (CAP)(Baseline, up to 365 days)
- Change in otoacoustic emissions (OAE)(Baseline, up to 365 days)
研究者
Michael E. Hoffer
Professor
University of Miami