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

NCT07466056 | Recruiting DMC FDA Device

• 1 other identifier: AnzhenKS2026005
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Flexible Electronic Devices; Remote Management; Non-invasive Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Respiratory rate

  For three consecutive days, from 22:00 to 07:00 each day

• Temperature

  For three consecutive days, from 22:00 to 07:00 each day

Study Arms (1)

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

Interventions

Non-invasive Smart Mattress Monitoring System DEVICE

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.

Smart Mattress Monitoring Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.).
• 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.
• The patient cannot cooperate with bed rest due to their condition or mental factors.
• Severe respiratory diseases requiring mechanical assisted ventilation.
• Patients requiring assistance from other medical electronic devices or instruments (such as temporary cardiac pacemakers, bedside hemodialysis, etc.).

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China, 100029, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ning Zhou, Prof.

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu He, PhD.

CONTACT

+86 138-1072-0787; theliu@139.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Arrhythmia Center (Unit 1)

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)