Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States

Anesthesia Clinical Trial

Official title:

Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799417
• Other study ID #: 2022-00970
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: November 2023

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Friedrich Lesch, MD, MSc.
• Phone: +41 31 632 21 11
• Email: friedrich.lersch[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Sleep

Intervention

Other:
• Acoustic stimuli
During different states of sedation/anaesthesia and sleep, acoustic stimuli will be presented and compared to a within-subject baseline.

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain oscillatory power derived by EEG	Brain oscillatory response to acoustic stimuli derived by power spectral density in canonical frequency bands from 0.5 up to 40 Hz.	Continuously across anaesthesia/sedation/sleep up to 8 hours
Primary	Brain oscillatory response derived by Hilbert Amplitude	Brain oscillatory response to acoustic stimuli derived by Hilbert-transforming EEG data and extracting Hilbert amplitude in microVolts	Continuously across anaesthesia/sedation/sleep up to 8 hours
Primary	Spindle characteristics - number of spindles	Number of spindles	Continuously across anaesthesia/sedation/sleep up to 8 hours
Primary	Spindle characteristics - amplitude of spindles	Spindle amplitude in microVolts	Continuously across anaesthesia/sedation/sleep up to 8 hours
Primary	Spindle characteristics - frequency of spindles	Frequency of spindles in Hz	Continuously across anaesthesia/sedation/sleep up to 8 hours
Primary	Spindle characteristics - duration of spindles	Duration of spindles in ms	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Heart rate	Heart rate derived from echocardiogram in bpm	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Instantaneous heart rate	Instantaneous heart rate derived from echocardiogram in bpm	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Heart rate variability	Heart rate variability derived from echocardiogram in ms	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Slow wave characteristics - amplitude	Slow wave amplitude in microVolt	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Slow wave characteristics - number	Number of slow waves	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Slow wave characteristics - frequency	Frequency of slow waves in Hz	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Slow wave characteristics - slope	Slope of slow waves in microVolts/s	Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary	Number of sleep arousals		Continuously across sleep up to 8 hours