Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab

Study Overview
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Brief Summary
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Improvement of patients' care and outcome is largely based on development and validation of drugs and technologies, especially in rapidly evolving fields as Interventional Cardiology. In fact, even though the optimal efficiency of a cathlab can be influenced by Interventional Cardiologist's mental workload, stress' accumulation and performance, little if any attention is paid to the monitoring and optimization of his/her mental status. Electroencephalogram (EEG)-based neural-interfaces are able to estimate workload, fatigue and the degree of sleepiness through spectral analysis techniques. In particular, the amplitude of alpha waves is a widely validated indicator of mental engagement's level. Developing a low cost and highly feasible device to monitor and analyze operator's mental engagement level and performance could be extremely appealing, especially considering both the lack of data in literature for interventional disciplines and the recent technology developments.

Detailed Description
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The investigators will prospectively record and analyze Electroencephalogram (EEG) signals from 5 interventional cardiologists and 2 fellows in training in all consecutive procedures at Ferrara University Hospital. Considering the hypothesis of independence of the working shifts, given the heterogeneity of their structure in terms of procedures' number and type and their distance in time, it is then possible to assume that the same operator's psycho-physical state diverges between two different acquisition days. Muse S (InteraXon; Canada), a minimally invasive device paired via Bluetooth to a dedicated app, is used to record EEG signals. Neurometrics will be acquired during Alpha Attenuation Protocols (AAP), a sensitive test to quantify sleepiness which involves measuring alpha power during 2 cycle of eye opening/closing protocol, for a total amount of 4 minutes. AAP will be recorded at the beginning of the shift, before and after each procedure performed and allow to extrapolate waves' power measures obtained during resting condition (AA Coefficient-eyes open (AAC-eo), AAC-eyes closed (AAC-ec) and AAC-mean), related to fatigue, and AAC-ec/AAC-eo (AAC-ratio), related to sleepiness. In addition, alpha-prevalence (AP) during on-task will be measured. Alpha prevalence is an estimate of alpha-power. Investigators will also measure several validated psychometric questionnaires: Karolinska Sleepiness Scale (KSS), Sleep Quality Scale (SQS) and Profile of Mood States-Fatigue subscale (POMS-F). Heart rate variability (HRV) during tasks, related to psycho-physical stress, is assessed through the square root of the mean of the sum of squares of differences between adjacent normal R-R (rMSSD). The Game-on project aims to describe workload, mental fatigue and sleepiness through variation of psychometric and neurometric measurements during a work shift with the intent of establishing determinants of error and lengthening of procedural times.

Official Title
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Gauging Active Modalities of Error Detection and Signaling Obtained by Neural Interfaces in the Cathlab: The GAME-ON Study

Conditions
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Coronary Artery Disease, Stress, Psychological, Mental Stress

Intervention / Treatment
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* Other: Neural Interfaces Electroencephalogram measurement on Operators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication to coronary artery angiography and/or percutaneous coronary intervention Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing coronary artery angiography and/or percutaneous coronary intervention<br>Consecutive patients with indication to perform coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital | Other: Neural Interfaces Electroencephalogram measurement on Operators<br>* Electroencephalogram based neural interfaces acquired during the interventional procedure and during alpha attenuation protocols (AAP) and psychometric questionnaires. AAP and psychometrics are acquired at the beginning of the shift, before and after each procedure performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleepiness Sensitivity KSS | Sensitivity: proportion of operators with positive AAC ratio (AAC ratio values above study population median value are considered associated with sleepiness) of positive KSS questionnaire ones (true positive). KSS is defined as positive for values above preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | 
| Sleepiness Sensitivity SQS | Sensitivity: proportion of operators with positive AAC ratio of positive SQS questionnaire ones (true positive). SQS is defined as positive for values above preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | 
| Sleepiness Specificity KSS | Specificity: proportion of operators with negative AAC ratio (AAC ratio values below study population median value are not considered associated with sleepiness) of negative KSS questionnaire ones (true negative). KSS is defined as negative for values below preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | 
| Sleepiness Specificity SQS | Specificity: proportion of operators with negative AAC ratio (AAC ratio values below study population median value are not considered associated with sleepiness) of negative SQS questionnaire ones (true negative). SQS is defined as negative for values below preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | 
| Fatigue Sensitivity POMS-F | Sensitivity: proportion of operators with positive AAC ec/eo/mean (AAC ec/eo/mean values above study population median value are considered associated with fatigue) of positive POMS-F questionnaire ones (true positive). POMS-F is defined as positive for values above preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | 
| Fatigue Specificity POMS-F | Specificity: proportion of operators with negative AAC ec/eo/mean (AAC ec/eo/mean values below study population median value are not considered associated with fatigue) of negative POMS-F questionnaire ones (true negative). POMS-F is defined as negative for values below preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | 
| On task psycho-physical stress NASA-TLX | Proportion of operators with positive Alpha Prevalence (AP) eo (AP eo values above study population median value are considered associated with psychophysical stress) at the beginning of the procedure, end of the procedure and mean value during the procedure of operators with positive NASA-Task Load Index (TLX) (NASA-TLX value above preliminary study population median value (two months sampling of the same population between February and March 2021)). | intraprocedure | 
| On task psycho-physical stress rMSSD | Proportion of operators with positive AP eo (AP eo values above study population median value are considered associated with psychophysical stress) at the beginning of the procedure, end of the procedure and mean value during the procedure of operators with positive rMSSD (rMSSD value below preliminary study individual's mean value). | intraprocedure | 
| Correlation AP and rMSSD | Evaluate the correlation between AP and rMSSD curve during the procedure. Curves are built by evaluating AP and rMSSD values in 5 minutes slots all along the procedure. | intraprocedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC Fatigue POMS-F (positive) | Area under the curve (AUC) of AAC eo/ec/mean positive for POMS-F positive | pre-procedure | 
| AUC Sleepiness KSS/SQS | Area under the curve (AUC) of AAC ratio positive for KSS/SQS positive | pre-procedure | 
| Procedural lengthening | To discriminate whether positive AAC eo at the beginning of the procedure, at the end of the procedure and the mean value during the procedure is associated with longer procedure time, higher contrast volume and x-ray time after correction for confounders (clinical presentation, number of treated vessels, calcifications, etc.) | intraprocedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neural interfaces, attentional effort, mental fatigue, sleepiness, coronary artery disease, percutaneous coronary intervention