Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Brain oscillatory power derived by EEG
研究概览
简要总结
The investigators want to explore how presenting acoustic stimuli influences brain oscillatory signatures and heart rhythm- dynamics across different vigilance and sedation states.
The investigators will administer acoustic stimuli during sedation and anaesthesia while brain activity and heart activity are being recorded by electroencephalogram and electrocardiogram.
On the day following anaesthesia an optional nap/sleep period's EEG and ECG will be recorded. During this short sleep, patients will again be exposed to acoustic stimuli. The recorded EEG and ECG will be compared intra-and inter-individually to recordings from sedation and anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
This study is designed as non-randomized clinical study where acoustic stimuli of different characteristics are played and compared to within-subject baselines across various sedation and/or sleep states.
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Good general health status
- •Planned ophthalmic/plastic surgery at Inselspital Berne
排除标准
- •Contraindications on ethical grounds
- •Neurological/neurodegenerative disorder
- •Hearing problems (only if patients are not able to perceive the acoustic stimuli)
- •Pacemaker
- •Deep brain stimulator
- •Pregnancy
- •Known or suspected drug or alcohol abuse
- •Critical surgery procedure
结局指标
主要结局
Brain oscillatory power derived by EEG
时间窗: Continuously across anaesthesia/sedation/sleep up to 8 hours
Brain oscillatory response to acoustic stimuli derived by power spectral density in canonical frequency bands from 0.5 up to 40 Hz.
Brain oscillatory response derived by Hilbert Amplitude
时间窗: Continuously across anaesthesia/sedation/sleep up to 8 hours
Brain oscillatory response to acoustic stimuli derived by Hilbert-transforming EEG data and extracting Hilbert amplitude in microVolts
Spindle characteristics - number of spindles
时间窗: Continuously across anaesthesia/sedation/sleep up to 8 hours
Number of spindles
Spindle characteristics - amplitude of spindles
时间窗: Continuously across anaesthesia/sedation/sleep up to 8 hours
Spindle amplitude in microVolts
Spindle characteristics - frequency of spindles
时间窗: Continuously across anaesthesia/sedation/sleep up to 8 hours
Frequency of spindles in Hz
Spindle characteristics - duration of spindles
时间窗: Continuously across anaesthesia/sedation/sleep up to 8 hours
Duration of spindles in ms
次要结局
- Heart rate(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Instantaneous heart rate(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Heart rate variability(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Slow wave characteristics - amplitude(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Slow wave characteristics - number(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Slow wave characteristics - frequency(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Slow wave characteristics - slope(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- Number of sleep arousals(Continuously across sleep up to 8 hours)