Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Hearing thresholds
研究概览
简要总结
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.
详细描述
Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication. The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between 18 and 85 years of age
- •non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
- •cognitive performance within two standard deviations of the CERAD mean
排除标准
- •less than 18 or greater than 85 years of age
- •deafness or excessive hearing loss
- •smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
- •history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
- •regular use of prescription medications (excluding oral contraceptives)
- •drug dependency
研究组 & 干预措施
Nicotine gum
Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
干预措施: Nicotine gum (Other)
Placebo gum
The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
干预措施: Placebo gum (Other)
结局指标
主要结局
Hearing thresholds
时间窗: 1 hour
Hearing thresholds in dB SPL will be measured as a function of sound frequency from 125 Hz to 8000 Hz in quiet or in noise.
Envelope following responses
时间窗: 2 hours
Electrophysiological responses will be recorded in response to amplitude or frequency-modulated sounds. The sounds will be presented at 70 dB SPL or a comfortable level. The EEG signal strength that is in synchrony with the modulation frequency in micro-Volts will be recorded.
Modulation detection
时间窗: 1 hour
Amplitude-modulated sounds will be presented at 70 dB SPL or a comfortable level. The detection threshold in percent modulation depth (m= 0 to 100) will be recorded and converted into signal-to-noise ratios in dB (=20log(m)).
次要结局
- Nicotine side effects(10 minutes)
- Heart rate(10 minutes)
- Mood change(10 minutes)
研究者
Fan-Gang Zeng
Professor
University of California, Irvine