Evaluation of a Non-invasive Smart Mattress Device for Continuous Monitoring of Heart Rate, Respiration, Temperature, and Posture in Adults with Cardiovascular Disease

What this Trial Is About

Researchers are evaluating a non-invasive, mattress-based smart monitoring system designed to continuously and contact-free monitor vital signs such as heart rate, respiration, body temperature, and posture in patients with cardiovascular diseases. This study aims to validate the devices performance compared to traditional bedside ECG monitoring systems, supporting clinical care and long-term health management. The project is a single-center clinical evaluation integrating advanced technologies like artificial intelligence and cloud data processing to improve cardiovascular patient monitoring. The investigational device is a mattress embedded with flexible sensing fibers, placed on standard hospital beds to unobtrusively gather multiple physiological signals. The study has two phases the Validation Phase with the first 100 participants monitored simultaneously by both the smart mattress and conventional monitors for calibration, followed by the Primary Monitoring Phase where the next 1000 participants are monitored solely with the smart mattress for large-scale data collection. Data is transmitted wirelessly to secure servers for real-time analysis and integration with hospital information systems and personal health platforms. Participants will be inpatients admitted to the cardiovascular disease ward and monitored continuously overnight for three consecutive days from 10 PM to 7 AM. Researchers will assess heart rate and rhythm as the primary outcome, along with respiratory rate and temperature as secondary outcomes. The study collects large-scale physiological data in real-world clinical settings to generate personalized health reports and clinical recommendations. The total participation duration involves these continuous monitoring sessions, supporting future device development and regulatory approval.

Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases