Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab

NCT05041218 | Completed DMC

• 1 other identifier: OspFE_25082021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Mental Stress; Stress, Psychological

Keywords

neural interfaces; attentional effort; mental fatigue; sleepiness; coronary artery disease; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• AUC Fatigue POMS-F (positive)

  pre-procedure

• AUC Sleepiness KSS/SQS

  pre-procedure

• Procedural lengthening

  intraprocedure

Study Arms (1)

Patients undergoing coronary artery angiography and/or percutaneous coronary intervention

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

Interventions

Neural Interfaces Electroencephalogram measurement on Operators OTHER

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.

Patients undergoing coronary artery angiography and/or percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients undergoing invasive coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Ferrara, Italy

Location

Related Publications (4)

• 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.

  PMID: 29017780 BACKGROUND

• 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.

  PMID: 22832068 BACKGROUND

• 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.

  PMID: 30691989 BACKGROUND

• 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.

  PMID: 25224885 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Stress, Psychological; Mental Fatigue; Sleepiness

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simone Biscaglia, MD

  Azienda Ospedaliero Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

• Gianluca Campo, MD

  Azienda Ospedaliero Universitaria di Ferrara

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 10, 2021
• Study Start: May 9, 2023
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)