Coronary Artery DiseaseGAME-ONNCT05041218
Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab
An observational study of Coronary Artery Disease and Mental Stress, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Mental Stress, Stress, Psychological
- What is being tested?
- Neural Interfaces Electroencephalogram measurement on Operators
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2023to 24 Mar 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients undergoing invasive coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital
Who may be able to join
- indication to coronary artery angiography and/or percutaneous coronary intervention
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gauging Active Modalities of Error Detection and Signaling Obtained by Neural Interfaces in the Cathlab: The GAME-ON Study
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.
Read the 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.
- Being tested
- Neural Interfaces Electroencephalogram measurement on Operators
- Keywords
- neural interfaces, attentional effort, mental fatigue, sleepiness, coronary artery disease, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Stress, Psychological, Mental Fatigue, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Interfaces Electroencephalogram measurement on OperatorsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Neural Interfaces Electroencephalogram measurement on Operators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)).
Measured: 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).
Measured: 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.
Measured: intraprocedure
Secondary outcomes (3)
AUC Fatigue POMS-F (positive)
Area under the curve (AUC) of AAC eo/ec/mean positive for POMS-F positive
Measured: pre-procedure
AUC Sleepiness KSS/SQS
Area under the curve (AUC) of AAC ratio positive for KSS/SQS positive
Measured: 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.)
Measured: intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start9 May 2023
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Simone Biscaglia, MD, Principal investigator, Azienda Ospedaliero Universitaria di FerraraGianluca Campo, MD, Study chair, Azienda Ospedaliero Universitaria di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041218
- Sponsor's protocol ID
- OspFE_25082021
- Acronym
- GAME-ON
- Status last verified
- Mar 2025
- First submitted
- 26 Aug 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29017780Brouwer 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.
PubMed 22832068Morales 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.
PubMed 30691989Putilov 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.
PubMed 25224885
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gauging Active Modalities of Error Detection and Signaling Obtained by Neural Interfaces in the Cathlab: The GAME-ON Study
- ClinicalTrials.gov ID
- NCT05041218
- Acronym / sponsor ID
- GAME-ON / OspFE_25082021
- Keywords
- neural interfaces, attentional effort, mental fatigue, sleepiness, coronary artery disease, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing coronary artery angiography and/or percutaneous coronary intervention | – | Other: Neural Interfaces Electroencephalogram measurement on OperatorsConsecutive patients with indication to perform coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing invasive coronary artery angiography and/or percutaneous coronary intervention at Ferrara University Hospital
Key inclusion criteria (1 listed)
- indication to coronary artery angiography and/or percutaneous coronary intervention
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Interfaces Electroencephalogram measurement on OperatorsElectroencephalogram 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. | Other | Patients undergoing coronary artery angiography and/or percutaneous coronary intervention |
Primary outcome
Sleepiness Sensitivity KSS
Time frame: pre-procedure
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).
Sleepiness Sensitivity SQS
Time frame: pre-procedure
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).
Sleepiness Specificity KSS
Time frame: pre-procedure
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).
Sleepiness Specificity SQS
Time frame: pre-procedure
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).
Fatigue Sensitivity POMS-F
Time frame: pre-procedure
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).
Fatigue Specificity POMS-F
Time frame: pre-procedure
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).
On task psycho-physical stress NASA-TLX
Time frame: intraprocedure
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)).
On task psycho-physical stress rMSSD
Time frame: intraprocedure
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).
Correlation AP and rMSSD
Time frame: intraprocedure
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.
3 secondary outcomes
AUC Fatigue POMS-F (positive)
Time frame: pre-procedure
AUC Sleepiness KSS/SQS
Time frame: pre-procedure
Procedural lengthening
Time frame: intraprocedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Results publication: PubMed 29017780Puma 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.
- Results publication: PubMed 22832068Brouwer 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.
- Results publication: PubMed 30691989Morales 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.
- Results publication: PubMed 25224885Putilov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Biscaglia, MD principal investigator
Azienda Ospedaliero Universitaria di Ferrara
Gianluca Campo, MD study chair
Azienda Ospedaliero Universitaria di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Mental Stress, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleepiness Sensitivity KSS (time frame: pre-procedure). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041218, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.