Clinical trial NCT05019911: Prediction of Exacerbations and Management of COPD Patients With SAH Based on Millimeter Wave Radar Monitoring
Official title: Prediction of Exacerbations and Management of COPD Patients With Sleep Apnea Hypopnea Based on Millimeter Wave Radar Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Sleep Apnea Hypopnea Syndrome
Acute Exacerbation of COPD
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Tsinghua University
First posted: 2021-08-25
Enrollment: 922
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD alone and patients with COPD combined with sleep apnea hypopnea syndrome aged 40 years or older

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD in line with Group on Chronic Obstructive Pulmonary disease, Chinese Thoracic Society. Guidelines for the diagnosis and treatment of chronic obstructive pulmonary disease (2013 revised).
* Or with Clinical diagnosis of sleep apnea hypopnea in line with Group on sleep breathing disorders, Chinese Thoracic Society. Guidelines for the diagnosis and treatment of obstructive sleep apnea hypopnea syndrome (2011 revised).
* Aged 40 years or older.
* Must provide informed consent.

Exclusion Criteria:

* Cognitive disorders.
* Unable to join in the study and so on.

Primary outcomes:
measure: Apnea Hypopnea Index in times per hour
timeFrame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
measure: Oxygen saturation in percent
timeFrame: At baseline and millimeter wave radar monitoring and pulse oximeter continues during one month's or one year's follow-up
measure: Respiratory rate in breaths per minute
timeFrame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
measure: Heart rate in beats per minute
timeFrame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
measure: Chest/abdominal movement and others
timeFrame: At baseline and millimeter wave radar monitoring or other devices continues during one month's or one year's follow-up
measure: Diagnosis of COPD according to lung function
timeFrame: At baseline
measure: Diagnosis of sleep apnea hypopnea syndrome according to the times of apnea and hypopnea or AHI (RDI) with certain symptoms
timeFrame: At baseline
Secondary outcomes:
measure: The occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
timeFrame: During one month's or one year's follow-up
measure: The time of occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
timeFrame: During one month's or one year's follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tsinghua University
Study officials:
affiliation: Peking University Third Hospital
name: Yahong Chen
role: PRINCIPAL_INVESTIGATOR
References: