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

NCT05799417 | Unknown DMC

• 1 other identifier: 2022-00970
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Sleep

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• 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

Study Arms (1)

Acoustic stimuli

EXPERIMENTAL

Acoustic stimuli and comparison to within-subject baseline

Other: Acoustic stimuli

Interventions

Acoustic stimuli OTHER

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

Acoustic stimuli

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature
• Good general health status
• Planned ophthalmic/plastic surgery at Inselspital Berne

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, Switzerland

RECRUITING

Study Officials

• Friedrich Lersch

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Friedrich Lesch, MD, MSc.

CONTACT

+41 31 632 21 11; friedrich.lersch@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators forecast a maximal enrollment of 80 participants. However, an interim-analysis will be conducted after 10-14 participants to check estimated effect-size of intervention.

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 5, 2023
• Study Start: February 28, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)