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Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System

Clinical Effectiveness of Non-contact Heart Rate and Respiratory Rate Monitoring System

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06573203
Enrollment
70
Registered
2024-08-27
Start date
2024-08-21
Completion date
2026-12-31
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant,newborn, Sleep, Vital Signs

Keywords

Sleep monitoring, Vital signs were monitored, Study of correlation

Brief 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. 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.

Interventions

DEVICENon-contact heart rate and respiratory rate monitoring system

Each neonate enrolled underwent four sleep and vital signs monitoring procedures after admission.

DEVICEMindray ECG monitor

Heart rate and respiratory rate of each enrolled child were monitored after admission.

DEVICEaEEG

Each enrolled child underwent a 6-hour sleep-wake cycle, quiet sleep, and active sleep monitoring after admission.

OTHERNeonatal 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.

Sponsors

Jiaxing Yuanbeibei Technology Co. LTD
CollaboratorUNKNOWN
Children's Hospital, Zhejiang University School of Medicine
CollaboratorUNKNOWN
The Children's Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No

Inclusion criteria

* Newborns admitted to our hospital for the first time, with gestational age ≥28w; * Expected hospital stay ≥5 days.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep-wake state10minutes after the meal, 5minutes each time, two times in totalSleep-wake state scores derived from a contact-free heart rate and respiratory rate monitoring system and NSWST measurements.
Number of sleep cyclesThe hospital stay lasted 6 hoursThe number of sleep cycles obtained was monitored simultaneously by a non-contact heart rate and respiratory rate monitoring system and aEEG.
Proportion of quiet sleepThe hospital stay lasted 6 hoursnon-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 sleepThe hospital stay lasted 6 hoursnon-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.

Secondary

MeasureTime frameDescription
Heart rateThe hospital stay lasted 6 hoursHeart 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.
Respiratory rateThe hospital stay lasted 6 hoursRespiratory 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026