Clinical trial NCT05799417: Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States
Official title: Brain Oscillatory Signatures of Auditory Stimuli Across Different Vigilance and Sedation States
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Sleep
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Brain oscillatory power derived by EEG
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Brain oscillatory response derived by Hilbert Amplitude
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Spindle characteristics - number of spindles
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Spindle characteristics - amplitude of spindles
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Spindle characteristics - frequency of spindles
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Spindle characteristics - duration of spindles
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
Secondary outcomes:
measure: Heart rate
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Instantaneous heart rate
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Heart rate variability
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Slow wave characteristics - amplitude
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Slow wave characteristics - number
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Slow wave characteristics - frequency
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Slow wave characteristics - slope
timeFrame: Continuously across anaesthesia/sedation/sleep up to 8 hours
measure: Number of sleep arousals
timeFrame: Continuously across sleep up to 8 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Friedrich Lersch
role: PRINCIPAL_INVESTIGATOR
References: