NCT07248969

HERO System - Health Monitoring for the Detection of Vital Signs and Emotional States

Observational Pilot Study on the Use of the HERO Health Monitoring System for the Detection of Vital Signs, Emotional States, and Body Postures

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

New technologies offer significant opportunities to enhance the quality and intensity of care services, amplifying the ability to respond to patient needs through contactless solutions that also contribute to the humanization of care. Their application in patient monitoring can enable continuous observation, even in the absence of physically present staff, for a larger number of non-critical patients (thus reducing the risk of adverse events), and facilitate timely interventions when needed-aligned with the logic of Anglo-Saxon models based on Early Warning Systems. The general objective of this study is to conduct a pilot clinical trial of a specific solution based on Artificial Intelligence and Computer Vision, the HERO Health Monitoring (HHM) system, capable of detecting vital signs (heart rate, respiratory rate, blood oxygen saturation, and blood pressure), body posture, movements, and patients' emotional states-such as expressions of pain-using simple video devices. The study aims, in particular, to measure the concordance of the system's vital sign measurements with standard (telemetric) systems, and to assess the added value of combining these measurements with the additional information provided by HHM regarding posture, movement, and emotional state analysis-once their agreement has been verified against patient-reported outcomes collected via self-assessment questionnaires. This is an observational study involving the HERO Health Monitoring medical device, for which the certification process is expected to be completed through the present study.

Conditions

• Cardiovascular

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-08-01
• Completion: 2025-12-31
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: Italy