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
- Diseases
- Coronary artery disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.