Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Brain oscillatory power derived by EEG
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed Consent as documented by signature
- •Good general health status
- •Planned ophthalmic/plastic surgery at Inselspital Berne
Exclusion Criteria
- •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
Arms & Interventions
Acoustic stimuli
Acoustic stimuli and comparison to within-subject baseline
Intervention: Acoustic stimuli (Other)
Outcomes
Primary Outcomes
Brain oscillatory power derived by EEG
Time Frame: 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
Time Frame: 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
Time Frame: Continuously across anaesthesia/sedation/sleep up to 8 hours
Number of spindles
Spindle characteristics - amplitude of spindles
Time Frame: Continuously across anaesthesia/sedation/sleep up to 8 hours
Spindle amplitude in microVolts
Spindle characteristics - frequency of spindles
Time Frame: Continuously across anaesthesia/sedation/sleep up to 8 hours
Frequency of spindles in Hz
Spindle characteristics - duration of spindles
Time Frame: Continuously across anaesthesia/sedation/sleep up to 8 hours
Duration of spindles in ms
Secondary Outcomes
- Instantaneous heart rate(Continuously across anaesthesia/sedation/sleep up to 8 hours)
- 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)