Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05041218
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2021-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D000077260', 'term': 'Sleepiness'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleepiness Sensitivity KSS', 'timeFrame': 'pre-procedure', 'description': '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).'}, {'measure': 'Sleepiness Sensitivity SQS', 'timeFrame': 'pre-procedure', 'description': '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).'}, {'measure': 'Sleepiness Specificity KSS', 'timeFrame': 'pre-procedure', 'description': '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).'}, {'measure': 'Sleepiness Specificity SQS', 'timeFrame': 'pre-procedure', 'description': '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).'}, {'measure': 'Fatigue Sensitivity POMS-F', 'timeFrame': 'pre-procedure', 'description': '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).'}, {'measure': 'Fatigue Specificity POMS-F', 'timeFrame': 'pre-procedure', 'description': '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).'}, {'measure': 'On task psycho-physical stress NASA-TLX', 'timeFrame': 'intraprocedure', 'description': '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)).'}, {'measure': 'On task psycho-physical stress rMSSD', 'timeFrame': 'intraprocedure', 'description': "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)."}, {'measure': 'Correlation AP and rMSSD', 'timeFrame': 'intraprocedure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'AUC Fatigue POMS-F (positive)', 'timeFrame': 'pre-procedure', 'description': 'Area under the curve (AUC) of AAC eo/ec/mean positive for POMS-F positive'}, {'measure': 'AUC Sleepiness KSS/SQS', 'timeFrame': 'pre-procedure', 'description': 'Area under the curve (AUC) of AAC ratio positive for KSS/SQS positive'}, {'measure': 'Procedural lengthening', 'timeFrame': 'intraprocedure', 'description': '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.)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neural interfaces', 'attentional effort', 'mental fatigue', 'sleepiness', 'coronary artery disease', 'percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease', 'Mental Stress', 'Stress, Psychological']}, 'referencesModule': {'references': [{'pmid': '29017780', 'type': 'BACKGROUND', '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.'}, {'pmid': '22832068', 'type': 'BACKGROUND', '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.'}, {'pmid': '30691989', 'type': 'BACKGROUND', '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.'}, {'pmid': '25224885', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nDeveloping 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.", 'detailedDescription': "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).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients undergoing invasive coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication to coronary artery angiography and/or percutaneous coronary intervention\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05041218', 'acronym': 'GAME-ON', 'briefTitle': 'Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Gauging Active Modalities of Error Detection and Signaling Obtained by Neural Interfaces in the Cathlab: the GAME-ON Study', 'orgStudyIdInfo': {'id': 'OspFE_25082021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing coronary artery angiography and/or percutaneous coronary intervention', 'description': 'Consecutive patients with indication to perform coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital', 'interventionNames': ['Other: Neural Interfaces Electroencephalogram measurement on Operators']}], 'interventions': [{'name': 'Neural Interfaces Electroencephalogram measurement on Operators', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Patients undergoing coronary artery angiography and/or percutaneous coronary intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ferrara', 'country': 'Italy', 'facility': 'University Hospital of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'overallOfficials': [{'name': 'Simone Biscaglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero Universitaria di Ferrara'}, {'name': 'Gianluca Campo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Azienda Ospedaliero Universitaria di Ferrara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gianluca Campo', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}