Cardiovascular DiseaseNCT07466056
Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases
An observational study of Cardiovascular Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Non-invasive Smart Mattress Monitoring System
- Type of treatment
- Medical device
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Sep 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.).
- The research team, after assessment, considers that there are other patients who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029
Liu He, PhD., +86 138-1072-0787, theliu@139.com
Ning Zhou, Prof.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Non-invasive Smart Mattress Monitoring System
- Keywords
- Cardiovascular disease, Flexible Electronic Devices, Remote Management, Non-invasive Monitoring
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Smart Mattress Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Non-invasive Smart Mattress Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate and Heart Rhythm
Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring.
Measured: For three consecutive days, from 22:00 to 07:00 each day
Secondary outcomes (2)
Respiratory rate
Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring
Measured: 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
Measured: For three consecutive days, from 22:00 to 07:00 each day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Oct 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NingZhou, Beijing Anzhen Hospital
- Investigators
- Ning Zhou, Prof., Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466056
- Sponsor's protocol ID
- AnzhenKS2026005
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Non-inductive Intelligent Physical Sign Monitoring Equipment Based on Flexible Electronic Devices in the Diagnosis and Treatment of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT07466056
- Acronym / sponsor ID
- AnzhenKS2026005
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Flexible Electronic Devices, Remote Management, Non-invasive Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart Mattress Monitoring Cohort | – | Device: Non-invasive Smart Mattress Monitoring SystemAll 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Smart Mattress Monitoring SystemThe 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. | Device | Smart Mattress Monitoring Cohort |
Primary outcome
Heart Rate and Heart Rhythm
Time frame: For three consecutive days, from 22:00 to 07:00 each day
Conventional vital signs monitoring devices or smart sensors embedded in mattresses for monitoring.
2 secondary outcomes
Respiratory rate
Time frame: For three consecutive days, from 22:00 to 07:00 each day
Temperature
Time frame: For three consecutive days, from 22:00 to 07:00 each day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Zhou, Prof. principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu He, PhD. (+86 138-1072-0787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate and Heart Rhythm (time frame: For three consecutive days, from 22:00 to 07:00 each day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.