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

This project is a single-center clinical evaluation study designed to validate a non-invasive mattress-based smart monitoring system. The system is intended for installation on standard hospital beds to provide continuous, contact-free monitoring of vital signs, including heart rate, respiration, body temperature, and posture, in patients with cardiovascular diseases. The system will integrate monitoring data with hospital information systems and personal health platforms to support clinical management and remote health monitoring.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Device: Non-invasive Smart Mattress Monitoring System

Detailed Description

In the diagnosis, treatment, and rehabilitation of cardiovascular diseases, accurate monitoring of key physiological signs provides the fundamental basis for clinicians to assess patient status and formulate treatment strategies. Traditional monitoring instruments used to acquire physiological data, such as electrocardiogram (ECG) monitors and polysomnography systems, require physical connections through electrode leads or ECG patches, which may increase patient discomfort and the risk of adverse events. Therefore, the development of monitoring devices with non-invasive and multi-parameter sensing capabilities is of significant importance for clinical care, nursing practice, and long-term health management.

This project focuses on the development and clinical evaluation of a non-invasive intelligent monitoring device for human physiological signals. The device is designed in the form of a mattress installed on a conventional hospital bed to enable real-time, accurate, continuous, and non-invasive monitoring of important physiological parameters in cardiovascular patients, including heart rate, respiration, body temperature, and body posture. Monitoring data will be integrated with hospital information systems and patient-side digital platforms to support clinical decision-making, disease management, and remote health monitoring.

A clinical evaluation will be conducted prior to product commercialization to determine whether the monitoring performance of the mattress-based system is non-inferior to that of conventional bedside ECG monitoring systems. Large-scale, long-term, and continuous physiological data from cardiovascular patients will be collected and analyzed in real-world clinical settings. Advanced technologies, including artificial intelligence and cloud-based data processing, will be applied to store, analyze, and interpret physiological signals. These data will enable the generation of personalized health monitoring reports and corresponding clinical recommendations.

The results of this study are expected to provide essential clinical evidence supporting the development and industrialization of the non-invasive intelligent monitoring system. In addition, the study will generate key data required for device research and development, quality control standards, regulatory evaluation, and medical device registration certification, ultimately facilitating the stepwise translation of the technology into clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Liu He, PhD.; Phone Number: +86 138-1072-0787; Email: theliu@139.com

Study Locations

• China
  • China
    • Beijing, China, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital, Capital Medical University
      • Principal Investigator: Ning Zhou, Prof.
      • Contact: Liu He, PhD.; Phone Number: +86 138-1072-0787; Email: theliu@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study aims to enroll adult inpatients from the cardiovascular disease ward to evaluate the performance of a non-invasive smart mattress monitoring system. Participants will be recruited based on their ability to comply with study procedures and provide informed consent.

Description

Inclusion Criteria:

1. Adult inpatients (aged ≥18 years) admitted to the cardiovascular disease ward.
2. Willing to sign the informed consent form in person.
3. Capable of understanding and following the research instructions, as well as having the language ability to communicate and fill out the relevant questionnaires.

Exclusion Criteria:

1. The patient has an allergic reaction to any materials related to the research equipment or test materials (such as traditional monitoring instruments, mattress fibers, etc.).
2. There are serious diseases that require urgent medical intervention, such as hypertensive emergencies, acute myocardial infarction, acute heart failure, acute stroke, severe ventricular arrhythmias, and shock, etc.
3. The patient cannot cooperate with bed rest due to their condition or mental factors.
4. Severe respiratory diseases requiring mechanical assisted ventilation.
5. Patients requiring assistance from other medical electronic devices or instruments (such as temporary cardiac pacemakers, bedside hemodialysis, etc.).
6. The research team, after assessment, considers that there are other patients who do not meet the inclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Smart Mattress Monitoring Cohort; All enrolled participants with cardiovascular conditions are monitored using the investigational non-invasive smart mattress system. The study involves two sequential phases: Validation Phase (First 100 participants): Participants undergo simultaneous monitoring by both the investigational smart mattress and a conventional reference device (e.g., bedside ECG monitor) for algorithm calibration and performance validation. Primary Monitoring Phase (Subsequent 1000 participants): Participants are monitored solely by the calibrated smart mattress system for large-scale, continuous vital sign data collection (heart rate, respiration, temperature, posture) in a real-world clinical setting.

Device: Non-invasive Smart Mattress Monitoring System; The investigational intervention is a mattress-form monitoring device embedded with flexible sensing fibers and a multi-parameter data acquisition system. It is placed atop a standard hospital bed to unobtrusively and continuously measure vital signs including heart rate, respiratory rate, body temperature, and body posture. The device transmits data wirelessly to a secure server for real-time display, storage, and analysis via dedicated software algorithms. In the initial validation phase (first 100 participants), its measurements are synchronously compared with those from conventional bedside monitors. In the subsequent primary monitoring phase, it functions as the sole continuous monitoring tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate and Heart Rhythm	Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring.	For three consecutive days, from 22:00 to 07:00 each day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring	For three consecutive days, from 22:00 to 07:00 each day
Temperature	Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring	For three consecutive days, from 22:00 to 07:00 each day

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Ning Zhou, Prof., Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Non-invasive Monitoring; Remote Management; Flexible Electronic Devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: AnzhenKS2026005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No