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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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.

Study Groups

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Acoustic stimuli

Acoustic stimuli and comparison to within-subject baseline

Group Type EXPERIMENTAL

Acoustic stimuli

Intervention Type OTHER

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

Interventions

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Acoustic stimuli

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No