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NCT05041218: GAME-ON
Neural Interfaces to Monitor Fatigue and Sleepiness in the Cathlab
trial testing Neural Interfaces Electroencephalogram measurement on Operators in Coronary Artery Disease in 500 participants. Completed in 24 March 2025.
24 March 2025
Quick facts
| Lead sponsor | University Hospital of Ferrara |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 9 May 2023 |
| Primary completion | 24 March 2025 |
| Estimated completion | 24 March 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Neural Interfaces Electroencephalogram measurement on Operators
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Mental Stress — all drugs for Mental Stress →
- Stress, Psychological — all drugs for Stress, Psychological →
Sponsor
University Hospital of Ferrara
Who can join
18 and older, any sex, with Coronary Artery Disease or Mental Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05041218
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital of Ferrara trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05041218 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital of Ferrara
- Last refreshed: 27 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05041218.
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