Non-contact smart mattress for continuous monitoring of heart rate, breathing, temperature, and posture

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

This project will test a non-contact smart mattress that continuously monitors heart rate, breathing, body temperature, and posture for adults hospitalized with cardiovascular disease.

Quick facts

• Study type: Observational
• Enrollment: 1100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, China)
• Trial ID: NCT07466056 on ClinicalTrials.gov

What this trial studies

This single-center clinical evaluation will test a mattress-shaped, non-invasive sensor system installed on standard hospital beds to record continuous heart rate, respiration, body temperature, and patient posture in adults admitted for cardiovascular disease. Monitoring data will be integrated with hospital information systems and patient-side digital platforms to support clinical management and remote follow-up. The mattress performance will be compared with routine monitoring approaches during inpatient care to determine accuracy and reliability before potential commercialization. Patients with severe acute conditions or those requiring mechanical ventilation are excluded from participation.

Who should consider this trial

Good fit: Adults (≥18) admitted to the cardiovascular ward at Beijing Anzhen Hospital who can give informed consent, understand study procedures, and can remain on bed rest as required are ideal candidates.

Not a fit: Patients with urgent life‑threatening conditions, those requiring mechanical ventilation or other supporting medical electronic devices, individuals allergic to mattress materials, or those unable to cooperate with bed rest are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, the mattress could provide comfortable, continuous, contact-free vital sign monitoring that supports bedside care and remote follow-up for people with heart disease.

How similar studies have performed: Non-contact bed sensors and ballistocardiography approaches have shown feasibility in prior smaller studies, but large-scale clinical validation for routine cardiovascular inpatient care remains limited.

Eligibility criteria

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.

Where this trial is running

Beijing, China

• Beijing Anzhen Hospital, Capital Medical University — Beijing, China, China (Recruiting)

Study contacts

• Principal investigator: Ning Zhou, Prof. — Beijing Anzhen Hospital
• Study coordinator: Liu He, PhD.

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