SleepNCT06573203
Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
A study testing Non-contact heart rate and respiratory rate monitoring system, Mindray ECG monitor and aEEG in people with Sleep and Infant，newborn, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Sleep, Infant，newborn, Vital Signs
- What is being tested?
- Non-contact heart rate and respiratory rate monitoring system, Mindray ECG monitor and aEEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns admitted to our hospital for the first time, with gestational age ≥28w;
- Expected hospital stay ≥5 days.
Who cannot join
- Apgar score ≤3 at 1 or 5 min after birth;
- Severe congenital malformation; Severe hypoxic-ischemic encephalopathy, intraventricular hemorrhage of grade III and above; There were serious heart and lung diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Children's Hospital Affiliated to the Medical College of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.
Read the detailed description
The non-contact heart rate and respiratory rate monitoring system collected the body vibration signals of children through the heart rate and respiratory rate sensor, converted the pressure signals of vibration into electrical signals, extracted heart rate and respiratory rate, and extracted the characteristic parameters of sleep stages using heart rate and respiratory rate and body movement signals. It is characterized by no need to wear any equipment, the monitoring mattress is placed under the original baby mattress, no direct contact with the skin of the child, no comfort, and no change in the original sleep habits.
- Conditions
- Sleep, Infant，newborn, Vital Signs
- Being tested
- Non-contact heart rate and respiratory rate monitoring system, Mindray ECG monitor, aEEG, Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.
- Keywords
- Sleep monitoring, Vital signs were monitored, Study of correlation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contact heart rate and respiratory rate monitoring systemDevice
Also called model YBB-B1
Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.
Mindray ECG monitorDevice
Also called model cPM 10C
Heart rate and respiratory rate of each enrolled child were monitored after admission.
aEEGDevice
Also called model Nicolet EEG V32
Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.
Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.Other
The study nurses observed and scored the children's sleep-wake status 10 minutes after two meals during the mattress test period, each time for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Non-contact heart rate and respiratory rate monitoring system | Experimental | After admission, the non-contact mattress is placed under a normal mattress, and heart rate, respiratory rate, and sleep-related parameters can be collected through induction. Receives: Device: Mindray ECG monitor; Device: aEEG; Other: Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity. |
| Electrocardiogram monitor | Active comparator | Measuring vital signs Receives: Device: Non-contact heart rate and respiratory rate monitoring system |
| Amplitude-integrated EEG | Active comparator | Sleep parameters were continuously measured by aEEG for 6 hours after admission. Receives: Device: Non-contact heart rate and respiratory rate monitoring system |
| Neonatal Sleep-Wake Assessment Tool | Active comparator | It is suitable for all newborns to observe and evaluate the sleep phase, wake period and regularity, and guide the choice of care time. The scale includes four dimensions: eye movement, breathing rate, facial expression and muscle activity. The score range of each dimension is 0 ~ 2 points, and the score range is 0 ~ 8 points. Receives: Device: Non-contact heart rate and respiratory rate monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep-wake state
Sleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements.
Measured: 10minutes after the meal, 5minutes each time, two times in total
Number of sleep cycles
The number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG.
Measured: The hospital stay lasted 6 hours
Proportion of quiet sleep
non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the quiet sleep time for 6 hours, and then the proportion of quiet sleep was calculated.
Measured: The hospital stay lasted 6 hours
Proportion of active sleep
non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the active sleep time for 6 hours, and then the proportion of active sleep was calculated.
Measured: The hospital stay lasted 6 hours
Secondary outcomes (2)
Heart rate
Heart rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average heart rate was calculated.
Measured: The hospital stay lasted 6 hours
Respiratory rate
Respiratory rate was measured simultaneously by non-contact heart rate and respiratory rate monitoring system and electrocardiogram monitor for 6 hours, and the average respiratory rate was calculated.
Measured: The hospital stay lasted 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start21 Aug 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiaxing Yuanbeibei Technology Co. LTD
- Responsible party
- Principal investigator, Shujun Li, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Hongzhen Xu, Principal investigator, The Children's Hospital Affiliated to the Medical College of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573203
- Sponsor's protocol ID
- 2024-IEC-0024-P-01
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System
- ClinicalTrials.gov ID
- NCT06573203
- Acronym / sponsor ID
- 2024-IEC-0024-P-01
- Conditions
- Sleep, Infant，newborn, Vital Signs
- Keywords
- Sleep monitoring, Vital signs were monitored, Study of correlation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Jiaxing Yuanbeibei Technology Co. LTD
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2024 (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.
In this study, hospitalized neonates were taken as the focus of the study. The non-contact heart rate and respiratory rate monitoring system was used to measure heart rate, respiratory rate, sleep parameters, ECG monitor, neonatal sleep-wake scale, amplitude-integrated electroencephalography. aEEG), in order to provide a theoretical basis for standardizing the operation of medical staff and formulating sleep protection strategies in the future, so as to promote the sleep quality of hospitalized neonates and improve the prognosis of neonates.
Detailed description
The non-contact heart rate and respiratory rate monitoring system collected the body vibration signals of children through the heart rate and respiratory rate sensor, converted the pressure signals of vibration into electrical signals, extracted heart rate and respiratory rate, and extracted the characteristic parameters of sleep stages using heart rate and respiratory rate and body movement signals. It is characterized by no need to wear any equipment, the monitoring mattress is placed under the original baby mattress, no direct contact with the skin of the child, no comfort, and no change in the original sleep habits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-contact heart rate and respiratory rate monitoring system | Experimental | Device: Mindray ECG monitor, Device: aEEG, Other: Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.After admission, the non-contact mattress is placed under a normal mattress, and heart rate, respiratory rate, and sleep-related parameters can be collected through induction. |
| Electrocardiogram monitor | Active comparator | Device: Non-contact heart rate and respiratory rate monitoring systemMeasuring vital signs |
| Amplitude-integrated EEG | Active comparator | Device: Non-contact heart rate and respiratory rate monitoring systemSleep parameters were continuously measured by aEEG for 6 hours after admission. |
| Neonatal Sleep-Wake Assessment Tool | Active comparator | Device: Non-contact heart rate and respiratory rate monitoring systemIt is suitable for all newborns to observe and evaluate the sleep phase, wake period and regularity, and guide the choice of care time. The scale includes four dimensions: eye movement, breathing rate, facial expression and muscle activity. The score range of each dimension is 0 ~ 2 points, and the score range is 0 ~ 8 points. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborns admitted to our hospital for the first time, with gestational age ≥28w;
- Expected hospital stay ≥5 days.
Key exclusion criteria (2 listed)
- Apgar score ≤3 at 1 or 5 min after birth;
- Severe congenital malformation; Severe hypoxic-ischemic encephalopathy, intraventricular hemorrhage of grade III and above; There were serious heart and lung diseases.
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-contact heart rate and respiratory rate monitoring systemAlso: model YBB-B1Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission. | Device | Amplitude-integrated EEG, Electrocardiogram monitor, Neonatal Sleep-Wake Assessment Tool |
| Mindray ECG monitorAlso: model cPM 10CHeart rate and respiratory rate of each enrolled child were monitored after admission. | Device | Non-contact heart rate and respiratory rate monitoring system |
| aEEGAlso: model Nicolet EEG V32Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission. | Device | Non-contact heart rate and respiratory rate monitoring system |
| Neonatal Sleep-Wake Assessment Tool (NSWAT) included four dimensions: eye movement, respiratory rate, facial expression and muscle activity.The study nurses observed and scored the children's sleep-wake status 10 minutes after two meals during the mattress test period, each time for 5 minutes. | Other | Non-contact heart rate and respiratory rate monitoring system |
Primary outcome
Sleep-wake state
Time frame: 10minutes after the meal, 5minutes each time, two times in total
Sleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements.
Number of sleep cycles
Time frame: The hospital stay lasted 6 hours
The number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG.
Proportion of quiet sleep
Time frame: The hospital stay lasted 6 hours
non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the quiet sleep time for 6 hours, and then the proportion of quiet sleep was calculated.
Proportion of active sleep
Time frame: The hospital stay lasted 6 hours
non-contact heart rate and respiratory rate monitoring system and aEEG were used to simultaneously measure the active sleep time for 6 hours, and then the proportion of active sleep was calculated.
2 secondary outcomes
Heart rate
Time frame: The hospital stay lasted 6 hours
Respiratory rate
Time frame: The hospital stay lasted 6 hours
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 5 Mar 2025.
- 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. This study is not recruiting at the moment.
Hongzhen Xu principal investigator
The Children's Hospital Affiliated to the Medical College of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contact heart rate and respiratory rate monitoring system, Mindray ECG monitor and aEEG in people with Sleep and Infant，newborn, run by The Children's Hospital of Zhejiang University School of Medicine 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep-wake state (time frame: 10minutes after the meal, 5minutes each time, two times in total). The study lists 4 primary outcomes in all. 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 5 Mar 2025.