COPDNCT05019911
Prediction of Exacerbations and Management of COPD Patients With SAH Based on Millimeter Wave Radar Monitoring
An observational study of COPD and Sleep Apnea Hypopnea Syndrome, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Sleep Apnea Hypopnea Syndrome, Acute Exacerbation of COPD
- What is being tested?
- Polysomnography and Millimeter wave radar equipment
- Type of treatment
- Medical device
- How many people
- 922 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD alone and patients with COPD combined with sleep apnea hypopnea syndrome aged 40 years or older
Who may be able to join
- 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.
Who cannot join
- Cognitive disorders.
- Unable to join in the study and so on.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Exacerbations and Management of COPD Patients With Sleep Apnea Hypopnea Based on Millimeter Wave Radar Monitoring
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.
Read the 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.
- Being tested
- Polysomnography, Millimeter wave radar equipment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
In the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome.
Millimeter wave radar equipmentDevice
In the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by millimeter wave radar equipment for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome. In the cohort part, both groups of patients will be continuously monitored by millimeter wave radar equipment for vital signs for months in order to establish a model to predict acute exacerbations of COPD combined with sleep apnea hypopnea syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD alone | In the cross-sectional part, the group of patients with COPD alone will be monitored by traditional sleep monitoring equipment (polysomnography) and millimeter wave radar equipment. In the cohort part, this group of patients will be continuously monitored by millimeter wave radar equipment for vital signs combined with pulse oxygen saturation, end expiratory CO2 and other indicators continuously monitored. Receives: Device: Polysomnography; Device: Millimeter wave radar equipment | |
| Patients with COPD combined with sleep apnea hypopnea syndrome | In the cross-sectional part, the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) and millimeter wave radar equipment. In the cohort part, this group of patients will be continuously monitored by millimeter wave radar equipment for vital signs combined with pulse oxygen saturation, end expiratory CO2 and other indicators continuously monitored. Receives: Device: Polysomnography; Device: Millimeter wave radar equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index in times per hour
AHI will be calculated by dividing times of apnea and hypopnea by hours of evaluation period during sleep.
AHI will be monitored by millimeter wave radar devices and polysomnography.
Measured: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Oxygen saturation in percent
Oxygen saturation will be monitored by millimeter wave radar devices, polysomnography or pulse oximeter.
Measured: At baseline and millimeter wave radar monitoring and pulse oximeter continues during one month's or one year's follow-up
Respiratory rate in breaths per minute
Respiratory rate will be monitored by millimeter wave radar devices and polysomnography.
Measured: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Heart rate in beats per minute
Heart rate will be monitored by millimeter wave radar devices and polysomnography.
Measured: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Chest/abdominal movement and others
Changes in chest/abdominal movement based on charts or indices and other non-specific measures will be monitored by millimeter wave radar devices or other devices.
Measured: At baseline and millimeter wave radar monitoring or other devices continues during one month's or one year's follow-up
Diagnosis of COPD according to lung function
The diagnosis of COPD is made according to the lung function criteria: post-bronchodilator FEV1 (forced expiratory volume at one second): FVC (forced vital capacity) less than 70%.
Measured: At baseline
Diagnosis of sleep apnea hypopnea syndrome according to the times of apnea and hypopnea or AHI (RDI) with certain symptoms
The diagnosis of sleep apnea hypopnea syndrome is made according to the times of apnea and hypopnea more than 30 during 7-hour's sleep per night, or AHI is 5 times per hour or more (or using respiratory disturbance index if possible), with primarily obstructive apnea, snore, sleep apnea, and daytime sleepiness.
Measured: At baseline
Secondary outcomes (2)
The occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
The occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome during follow-up
Measured: During one month's or one year's follow-up
The time of occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
The time of occurrence (from the prognosis data) of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome during follow-up
Measured: During one month's or one year's follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 922 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Sponsor
- Investigators
- Yahong Chen, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019911
- Sponsor's protocol ID
- M2021074
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Exacerbations and Management of COPD Patients With Sleep Apnea Hypopnea Based on Millimeter Wave Radar Monitoring
- ClinicalTrials.gov ID
- NCT05019911
- Acronym / sponsor ID
- M2021074
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 922 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 25 Aug 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD alone | – | Device: Polysomnography, Device: Millimeter wave radar equipmentIn the cross-sectional part, the group of patients with COPD alone will be monitored by traditional sleep monitoring equipment (polysomnography) and millimeter wave radar equipment. In the cohort part, this group of patients will be continuously monitored by millimeter wave radar equipment for vital signs combined with pulse oxygen saturation, end expiratory CO2 and other indicators continuously monitored. |
| Patients with COPD combined with sleep apnea hypopnea syndrome | – | Device: Polysomnography, Device: Millimeter wave radar equipmentIn the cross-sectional part, the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) and millimeter wave radar equipment. In the cohort part, this group of patients will be continuously monitored by millimeter wave radar equipment for vital signs combined with pulse oxygen saturation, end expiratory CO2 and other indicators continuously monitored. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD alone and patients with COPD combined with sleep apnea hypopnea syndrome aged 40 years or older
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Cognitive disorders.
- Unable to join in the study and so on.
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 |
|---|---|---|
| PolysomnographyIn the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome. | Device | Patients with COPD alone, Patients with COPD combined with sleep apnea hypopnea syndrome |
| Millimeter wave radar equipmentIn the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by millimeter wave radar equipment for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome. In the cohort part, both groups of patients will be continuously monitored by millimeter wave radar equipment for vital signs for months in order to establish a model to predict acute exacerbations of COPD combined with sleep apnea hypopnea syndrome. | Device | Patients with COPD alone, Patients with COPD combined with sleep apnea hypopnea syndrome |
Primary outcome
Apnea Hypopnea Index in times per hour
Time frame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
AHI will be calculated by dividing times of apnea and hypopnea by hours of evaluation period during sleep. AHI will be monitored by millimeter wave radar devices and polysomnography.
Oxygen saturation in percent
Time frame: At baseline and millimeter wave radar monitoring and pulse oximeter continues during one month's or one year's follow-up
Oxygen saturation will be monitored by millimeter wave radar devices, polysomnography or pulse oximeter.
Respiratory rate in breaths per minute
Time frame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Respiratory rate will be monitored by millimeter wave radar devices and polysomnography.
Heart rate in beats per minute
Time frame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Heart rate will be monitored by millimeter wave radar devices and polysomnography.
Chest/abdominal movement and others
Time frame: At baseline and millimeter wave radar monitoring or other devices continues during one month's or one year's follow-up
Changes in chest/abdominal movement based on charts or indices and other non-specific measures will be monitored by millimeter wave radar devices or other devices.
Diagnosis of COPD according to lung function
Time frame: At baseline
The diagnosis of COPD is made according to the lung function criteria: post-bronchodilator FEV1 (forced expiratory volume at one second): FVC (forced vital capacity) less than 70%.
Diagnosis of sleep apnea hypopnea syndrome according to the times of apnea and hypopnea or AHI (RDI) with certain symptoms
Time frame: At baseline
The diagnosis of sleep apnea hypopnea syndrome is made according to the times of apnea and hypopnea more than 30 during 7-hour's sleep per night, or AHI is 5 times per hour or more (or using respiratory disturbance index if possible), with primarily obstructive apnea, snore, sleep apnea, and daytime sleepiness.
2 secondary outcomes
The occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
Time frame: During one month's or one year's follow-up
The time of occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
Time frame: During one month's or one year's follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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.
Yahong Chen principal investigator
Peking University Third 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 COPD and Sleep Apnea Hypopnea Syndrome, run by Peking University Third 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 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahong Chen (861082266699, chenyahong@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index in times per hour (time frame: At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up). The study lists 7 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 25 Aug 2021.