Actively Recruiting
Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases
Led by Beijing Anzhen Hospital · Updated on 2026-03-13
1100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 device's 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.
CONDITIONS
Brief Title
Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult inpatients aged 18 years or older admitted to the cardiovascular disease ward
- Willing to sign the informed consent form in person
- Able to understand and follow research instructions and communicate effectively in the required language
You will not qualify if you...
- Allergy to any materials related to the research equipment or mattress fibers
- Serious diseases requiring urgent medical intervention such as hypertensive emergencies, acute myocardial infarction, acute heart failure, acute stroke, severe ventricular arrhythmias, or shock
- Inability to cooperate with bed rest due to condition or mental factors
- Severe respiratory diseases requiring mechanical ventilation
- Need for assistance from other medical electronic devices (e.g., temporary cardiac pacemakers, bedside hemodialysis)
- Other conditions assessed by the research team that do not meet inclusion criteria
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 consecutive days, from 10:00 PM to 7:00 AM each day
Participants are continuously monitored using the non-invasive smart mattress system to measure vital signs including heart rate, respiratory rate, body temperature, and body posture.
Monitoring occurs overnight for 3 consecutive nights
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, China, 100029
Actively Recruiting
Research Team
L
Liu He, PhD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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