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

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 Overview

• Status: Recruiting
• Conditions: Sleep; Anesthesia
• Intervention / Treatment: Other: Acoustic stimuli

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Friedrich Lesch, MD, MSc.; Phone Number: +41 31 632 21 11; Email: friedrich.lersch@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland
    • Recruiting
    • Inselspital
    • Contact: Friedrich Lersch; Email: friedrich.lersch@insel.ch
    • Contact: Stephanie Huwiler; Email: stephanie.huwiler@hest.ethz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acoustic stimuli; Acoustic stimuli and comparison to within-subject baseline	Other: Acoustic stimuli; During different states of sedation/anaesthesia and sleep, acoustic stimuli will be presented and compared to a within-subject baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Spindle characteristics - number of spindles	Number of spindles	Continuously across anaesthesia/sedation/sleep up to 8 hours
Spindle characteristics - amplitude of spindles	Spindle amplitude in microVolts	Continuously across anaesthesia/sedation/sleep up to 8 hours
Spindle characteristics - frequency of spindles	Frequency of spindles in Hz	Continuously across anaesthesia/sedation/sleep up to 8 hours
Spindle characteristics - duration of spindles	Duration of spindles in ms	Continuously across anaesthesia/sedation/sleep up to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate derived from echocardiogram in bpm	Continuously across anaesthesia/sedation/sleep up to 8 hours
Instantaneous heart rate	Instantaneous heart rate derived from echocardiogram in bpm	Continuously across anaesthesia/sedation/sleep up to 8 hours
Heart rate variability	Heart rate variability derived from echocardiogram in ms	Continuously across anaesthesia/sedation/sleep up to 8 hours
Slow wave characteristics - amplitude	Slow wave amplitude in microVolt	Continuously across anaesthesia/sedation/sleep up to 8 hours
Slow wave characteristics - number	Number of slow waves	Continuously across anaesthesia/sedation/sleep up to 8 hours
Slow wave characteristics - frequency	Frequency of slow waves in Hz	Continuously across anaesthesia/sedation/sleep up to 8 hours
Slow wave characteristics - slope	Slope of slow waves in microVolts/s	Continuously across anaesthesia/sedation/sleep up to 8 hours
Number of sleep arousals		Continuously across sleep up to 8 hours

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Friedrich Lersch, University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-00970 (Business Administration System for Ethics Committees (BASEC) number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No