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Clinical Trials/NCT05799417
NCT05799417
Recruiting
Not Applicable

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country80 target enrollmentFebruary 28, 2023
ConditionsAnesthesiaSleep

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
80
Locations
1
Primary Endpoint
Brain oscillatory power derived by EEG
Status
Recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2023
End Date
November 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

  • 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)

Study Sites (1)

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