Clinical trial NCT05041218: Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab
Official title: Gauging Active Modalities of Error Detection and Signaling Obtained by Neural Interfaces in the Cathlab: the GAME-ON Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Mental Stress
Stress, Psychological
Keywords: neural interfaces
attentional effort
mental fatigue
sleepiness
coronary artery disease
percutaneous coronary intervention
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients undergoing invasive coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* indication to coronary artery angiography and/or percutaneous coronary intervention

Exclusion Criteria:

* none

Primary outcomes:
measure: Sleepiness Sensitivity KSS
timeFrame: pre-procedure
measure: Sleepiness Sensitivity SQS
timeFrame: pre-procedure
measure: Sleepiness Specificity KSS
timeFrame: pre-procedure
measure: Sleepiness Specificity SQS
timeFrame: pre-procedure
measure: Fatigue Sensitivity POMS-F
timeFrame: pre-procedure
measure: Fatigue Specificity POMS-F
timeFrame: pre-procedure
measure: On task psycho-physical stress NASA-TLX
timeFrame: intraprocedure
measure: On task psycho-physical stress rMSSD
timeFrame: intraprocedure
measure: Correlation AP and rMSSD
timeFrame: intraprocedure
Secondary outcomes:
measure: AUC Fatigue POMS-F (positive)
timeFrame: pre-procedure
measure: AUC Sleepiness KSS/SQS
timeFrame: pre-procedure
measure: Procedural lengthening
timeFrame: intraprocedure
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
Study officials:
affiliation: Azienda Ospedaliero Universitaria di Ferrara
name: Simone Biscaglia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero Universitaria di Ferrara
name: Gianluca Campo, MD
role: STUDY_CHAIR
References:
citation: Puma S, Matton N, Paubel PV, Raufaste E, El-Yagoubi R. Using theta and alpha band power to assess cognitive workload in multitasking environments. Int J Psychophysiol. 2018 Jan;123:111-120. doi: 10.1016/j.ijpsycho.2017.10.004. Epub 2017 Oct 7.
citation: Brouwer AM, Hogervorst MA, van Erp JB, Heffelaar T, Zimmerman PH, Oostenveld R. Estimating workload using EEG spectral power and ERPs in the n-back task. J Neural Eng. 2012 Aug;9(4):045008. doi: 10.1088/1741-2560/9/4/045008. Epub 2012 Jul 25.
citation: Morales JM, Ruiz-Rabelo JF, Diaz-Piedra C, Di Stasi LL. Detecting Mental Workload in Surgical Teams Using a Wearable Single-Channel Electroencephalographic Device. J Surg Educ. 2019 Jul-Aug;76(4):1107-1115. doi: 10.1016/j.jsurg.2019.01.005. Epub 2019 Jan 26.
citation: Putilov AA, Donskaya OG. Alpha attenuation soon after closing the eyes as an objective indicator of sleepiness. Clin Exp Pharmacol Physiol. 2014 Dec;41(12):956-64. doi: 10.1111/1440-1681.12311.