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Clinical Trial Summary

Millimeter wave radar will be used to conduct non-contact monitoring continuously for patients' vital signs (eg. respiratory rate, heart rate, and chest/abdominal movement). The monitoring information will be transmitted to the central system through network and displayed in real time. Comparison with polysomnography will be done to examine the consistency between the two devices in diagnosing sleep breathing disorders. The predictive model of acute exacerbations of COPD will be established with the baseline indicators considered.


Clinical Trial Description

Significance: This study will conduct non-contact monitoring among COPD patients with sleep apnea hypopnea for respiratory rate, heart rate, respiratory rhythm and thoracic amplitude. This monitoring could not only offer patients a more comfortable medical environment, but also maintain high quality of monitoring, which would help build the platform for prediction and management of COPD combined with sleep breathing disorders with great clinical significance. Background: The misdiagnosis, underdiagnosis and disease burden of sleep breathing disorders in patients with COPD are high, which is one of the neglected problems in the management of COPD in China at present. The prevalence of obstructive sleep apnea (OSA) among COPD patients is 37.9-52.8%. Patients with overlapping COPD and OSA had more frequent hypoxemia during sleep and a longer total sleep duration for hypoxemia and hypercapnia than patients with OSA or COPD alone. The millimeter-wave radar equipment used in this study is from Qinglei Intelligent Health Care Life Support System. The system is based on millimeter wave radar intellisense and artificial intelligence technology, geared to the needs of health institutions, community endowment, family endowment, medical institutions, etc., to provide sleep monitoring, monitoring vital signs data, user behavior analysis, life vigor analysis, user exception alarm, falling alarm, diagnosis and screening of chronic respiratory disease, help with primary screening and early diagnosis of the disease and the patient-centered personalized precision diagnosis and treatment, enable early detection and treatment of health risks through scientific and technological means, and make more effective use of medical resources. The Peking University Third Hospital has actively promoted the construction of Internet-based medical services, and has passed the on-site evaluation of Internet hospital qualification, and realized Internet-based diagnosis and treatment. The Department of Respiratory and Critical Care Medicine has been engaged in clinical and applied basic research on COPD and its complications for a long time, which has a in-depth research foundation. Objective: To verify the consistency between millimeter wave radar equipment and traditional sleep monitoring equipment in the collection of respiratory rate, heart rate and respiratory movement of patients with COPD alone or COPD combined with sleep apnea hypopnea syndrome. Combined with pulse oxygen saturation, end expiratory CO2 monitoring and other indicators, the data model established is conducive to early detection of aggravation of COPD combined with sleep apnea hypopnea syndrome based on clinical indicators, which has important clinical value in practice. Content: Millimeter wave radar will be used to conduct non-contact monitoring continuously for patients' vital signs (eg. respiratory rate, heart rate, and chest/abdominal movement). The monitoring information will be transmitted to the central system through network and displayed in real time. Comparison with polysomnography will be done to examine the consistency between the two devices in diagnosing sleep breathing disorders. The predictive model of acute exacerbations of COPD will be established with the baseline indicators considered. Methods: The patients with COPD alone and patients with COPD combined with sleep apnea hypopnea were monitored by traditional sleep monitoring equipment and millimeter wave radar equipment. The patients were continuously monitored by millimeter wave radar equipment and followed up for acute exacerbation of COPD. Period: October 2021-September 2022 Expected results: The consistency between non-contact millimeter-wave radar equipment and routine clinical monitoring in the diagnosis of COPD combined with sleep apnea hypopnea syndrome. Based on the non-contact millimeter-wave radar equipment, a predictive model of acute exacerbation of COPD combined with sleep apnea hypopnea syndrome was established to provide evidence for the clinical application of radar equipment in the future. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05019911
Study type Observational
Source Peking University Third Hospital
Contact Yahong Chen
Phone 861082266699
Email chenyahong@vip.sina.com
Status Not yet recruiting
Phase
Start date October 2021
Completion date October 2022

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