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NCT05041218Completed

Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
500 (actual)
First submitted
26 Aug 2021
Start date
9 May 2023
Primary completion date
24 Mar 2025
Lead sponsor
University Hospital of Ferrara
NCT number
NCT05041218

What you commit to

  • Study type: Observational
  • Participants enrolled: 500
  • From 9 May 2023 to the primary completion date, 24 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • none

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Of Ferrara
Coordinator of this site? Confirm its status
FerraraItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.