COPDNCT05551169
Detect and Infer the Severity of COPD by Intelligent Terminal Device
An observational study of COPD, run by Peking University First Hospital at 10 sites in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases. Early detection and treatment are critical to prevent the deterioration of COPD. In this study, investigators aim to develop an algorithm that can detect and infer the severity level of COPD from physiological parameters and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 432 participants
- Where
- 10 sitesChina
- Study dates
- 21 Jun 2022to 11 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stage I: patients with stable COPD Stage 2: patients with stable COPD and non-COPD subjects
Who may be able to join
- Older than 18 years old, no gender limitation;
- In COPD stable stage (if there is an acute exacerbation, patients should be enrolled 3 months after remission of the exacerbation);
- Be able to carry out daily activities and wear wearable devices;
- Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
- Possess mobile communication equipment, which can meet the requirement of installing wearable device APP, and have a recording function.
- Older than 18 years old;
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- Be able to carry out daily activities and wear wearable devices;
- Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
- Possess mobile communication devices, which can meet the requirements of installing wearable devices APP, and have a recording function.
- Exclusion criteria: COPD and other serious chronic diseases (same exclusion criteria as COPD group).
Who cannot join
- Have been diagnosed with chronic respiratory diseases other than COPD, such as bronchial asthma, lung cancer, active tuberculosis, bronchiectasis, and diffuse lung diseases (interstitial pneumonia, occupational lung disease, sarcoidosis, etc.);
- lobectomy and/or lung transplantation, pleural disease;
- Complicated with serious underlying diseases, including severe mental illness, intellectually impaired diseases, neurological disease (resulting in limb movement disorder), malignant tumor (PS score > 2), chronic liver disease (transaminase > Normal high limit 3 times), heart failure (NYHA> Grade 3), autoimmune disease, chronic kidney disease (CKD-5), unstable coronary heart disease, arrhythmias (atrial fibrillation, atrial flutter, severe ventricular arrhythmia), congenital heart disease, pulmonary hypertension, etc., or life expectancy of less than 6 months;
- Malnutrition (BMI<18 kg/m2);
- Bilateral wrist and hand edema, wrist soft tissue injury, can not wear a watch/bracelet because of the incompleted skin;
- Double upper limb pigmentation or abnormal blood supply (occlusion, thrombosis, trauma, etc.) Stage 2 COPD group: Patients with stable COPD（same inclusion and exclusion criteria as Stage 1） Control group: healthy non-COPD population whose lung function must meet: FEV1/ FVC > 0.7, FEV1 > Pred 80% after bronchial dilation test when they are enrolled;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Aerospace 731 Hospital
Beijing, Beijing Municipality
Beijing Jingmei Group General Hospital
Beijing, Beijing Municipality
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Beijing Luhe Hospital
Beijing, Beijing Municipality
Beijing Miyun Hospital
Beijing, Beijing Municipality
Civil Aviation General Hospital
Beijing, Beijing Municipality
Peking University Shougang Hospital
Beijing, Beijing Municipality
People's Hospital of Beijing Daxing District
Beijing, Beijing Municipality
Shichahai community health service center
Beijing, Beijing Municipality
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality
About this study
Official title: Establishment of an Algorithm That Can Detect and Infer the Severity Level of COPD by Intelligent Terminal Device
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases. Early detection and treatment are critical to prevent the deterioration of COPD. In this study, investigators aim to develop an algorithm that can detect and infer the severity level of COPD from physiological parameters and audio data which are collected by a wearable device. Investigators will complete the study in two stages: stage 1. A panel study to assess the ability to infer the severity of COPD by intelligent terminal devices; stage 2. Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices.
Read the detailed description
In this study, investigators aim to establish an algorithm that can detect and infer the severity level of COPD from physiological parameters, coughing sounds, and forceful blowing sounds data that are collected by wearable devices.
This study is divided into two stages. Stage one: A panel study to assess the ability to infer the severity of COPD by intelligent terminal devices. 30 patients with stable COPD will be enrolled and will undergo pulmonary function tests, electrocardiogram, echocardiography measurement, blood gas analysis, six-minutes walking test (6MWT), and polysomnography. And they are required to fill in the questionnaires related to COPD every day. Physiological parameters including oxygen saturation, heart rate, sleep, and physical activity will be collected by a wearable device for 7-14 consecutive days. Coughing and forceful blowing sounds will be collected twice daily. The association between the severity of COPD and physiological parameters from the wearable device will be analyzed.
Stage two: Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices. 200 patients with stable COPD and 200 non- COPD subjects will be enrolled. Questionnaires related to COPD will be collected, and subjects will undergo pulmonary function tests and electrocardiograms. Physiological parameters including oxygen saturation and heart rate will be continuously collected by a wearable device for about 3～7 days. Investigators will also collect coughing and forceful blowing sounds. A COPD diagnosis algorithm model based on physiological parameters and audio data of intelligent terminal devices will be established.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2022-083). Any protocol modifications will be submitted for IRB review and approval.
- Conditions
- COPD
- Keywords
- COPD, Intelligent Terminal Device, Algorithm model
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stable COPD in Stage1 | no intervention | |
| Patients with stable COPD in Stage2 | no intervention | |
| Non-COPD subjects in Stage2 | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Association between the severity of COPD airflow restriction and data collected by wearable devices
Association between the severity of COPD airflow restriction and data collected by wearable devices
Measured: 2 months
Stage 2：Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices
Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices
Measured: 5 months
Secondary outcomes (4)
Stage 1: The compliance of subjects with wearable devices
The compliance of subjects with wearable devices is defined as the percentage of the actual completion time of data collection to the minimum required time (10 hours X 7 days=70 hours).
Measured: 2 months
Stage 1: Association between the severity of COPD airflow restriction, CAT score, mMRC score, echocardiography, blood gas analysis, six-minutes walking distance, polysomnography，and data collected by wearable devices
Association between the severity of COPD airflow restriction, CAT score, mMRC score, echocardiography, blood gas analysis, six-minutes walking distance, polysomnography，and data collected by wearable devices
Measured: 2 months
Stage 2: Association between the severity of COPD airflow restriction, CAT score, mMRC score，and data collected by wearable devices
Association between the severity of COPD airflow restriction, CAT score, mMRC score，and data collected by wearable devices
Measured: 5 months
Stage 2: number of adverse events
The number of adverse events
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start21 Jun 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Beijing Daxing District, Beijing Miyun Hospital, Civil Aviation General Hospital, Aerospace 731 Hospital, Beijing Shuyi Hospital, Shichahai community health service center, Peking University Shougang Hospital, General Hospital of Beijing Jingmei Group, Beijing Luhe Hospital, Beijing Jishuitan Hospital
- Responsible party
- Principal investigator, Guangfa Wang, Peking University First Hospital
- Investigators
- Guangfa Wang, MD, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551169
- Sponsor's protocol ID
- 2022083-0624
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang C, Yu K, Jin Z, Bao Y, Zhang C, Liao J, Wang G. Intelligent wearable devices with audio collection capabilities to assess chronic obstructive pulmonary disease severity. Digit Health. 2025 Mar 13;11:20552076251320730. doi: 10.1177/20552076251320730. eCollection 2025 Jan-Dec.
PubMed 40093702
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of an Algorithm That Can Detect and Infer the Severity Level of COPD by Intelligent Terminal Device
- ClinicalTrials.gov ID
- NCT05551169
- Acronym / sponsor ID
- 2022083-0624
- Conditions
- COPD
- Keywords
- COPD, Intelligent Terminal Device, Algorithm model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- People's Hospital of Beijing Daxing District, Beijing Miyun Hospital, Civil Aviation General Hospital, Aerospace 731 Hospital, Beijing Shuyi Hospital, Shichahai community health service center, Peking University Shougang Hospital, General Hospital of Beijing Jingmei Group, Beijing Luhe Hospital, Beijing Jishuitan Hospital
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 22 Sep 2022 (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.
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases. Early detection and treatment are critical to prevent the deterioration of COPD. In this study, investigators aim to develop an algorithm that can detect and infer the severity level of COPD from physiological parameters and audio data which are collected by a wearable device. Investigators will complete the study in two stages: stage 1. A panel study to assess the ability to infer the severity of COPD by intelligent terminal devices; stage 2. Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices.
Detailed description
In this study, investigators aim to establish an algorithm that can detect and infer the severity level of COPD from physiological parameters, coughing sounds, and forceful blowing sounds data that are collected by wearable devices.
This study is divided into two stages. Stage one: A panel study to assess the ability to infer the severity of COPD by intelligent terminal devices. 30 patients with stable COPD will be enrolled and will undergo pulmonary function tests, electrocardiogram, echocardiography measurement, blood gas analysis, six-minutes walking test (6MWT), and polysomnography. And they are required to fill in the questionnaires related to COPD every day. Physiological parameters including oxygen saturation, heart rate, sleep, and physical activity will be collected by a wearable device for 7-14 consecutive days. Coughing and forceful blowing sounds will be collected twice daily. The association between the severity of COPD and physiological parameters from the wearable device will be analyzed.
Stage two: Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices. 200 patients with stable COPD and 200 non- COPD subjects will be enrolled. Questionnaires related to COPD will be collected, and subjects will undergo pulmonary function tests and electrocardiograms. Physiological parameters including oxygen saturation and heart rate will be continuously collected by a wearable device for about 3～7 days. Investigators will also collect coughing and forceful blowing sounds. A COPD diagnosis algorithm model based on physiological parameters and audio data of intelligent terminal devices will be established.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2022-083). Any protocol modifications will be submitted for IRB review and approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with stable COPD in Stage1 | – | –no intervention |
| Patients with stable COPD in Stage2 | – | –no intervention |
| Non-COPD subjects in Stage2 | – | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stage I: patients with stable COPD Stage 2: patients with stable COPD and non-COPD subjects
Key inclusion criteria (10 listed)
- Older than 18 years old, no gender limitation;
- In COPD stable stage (if there is an acute exacerbation, patients should be enrolled 3 months after remission of the exacerbation);
- Be able to carry out daily activities and wear wearable devices;
- Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
- Possess mobile communication equipment, which can meet the requirement of installing wearable device APP, and have a recording function.
Key exclusion criteria (6 listed)
- Have been diagnosed with chronic respiratory diseases other than COPD, such as bronchial asthma, lung cancer, active tuberculosis, bronchiectasis, and diffuse lung diseases (interstitial pneumonia, occupational lung disease, sarcoidosis, etc.);
- lobectomy and/or lung transplantation, pleural disease;
- Complicated with serious underlying diseases, including severe mental illness, intellectually impaired diseases, neurological disease (resulting in limb movement disorder), malignant tumor (PS score > 2), chronic liver disease (transaminase > Normal high limit 3 times), heart failure (NYHA> Grade 3), autoimmune disease, chronic kidney disease (CKD-5), unstable coronary heart disease, arrhythmias (atrial fibrillation, atrial flutter, severe ventricular arrhythmia), congenital heart disease, pulmonary hypertension, etc., or life expectancy of less than 6 months;
- Malnutrition (BMI<18 kg/m2);
- Bilateral wrist and hand edema, wrist soft tissue injury, can not wear a watch/bracelet because of the incompleted skin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stage 1: Association between the severity of COPD airflow restriction and data collected by wearable devices
Time frame: 2 months
Association between the severity of COPD airflow restriction and data collected by wearable devices
Stage 2：Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices
Time frame: 5 months
Establish an algorithm that can detect and infer the severity level of COPD by intelligent terminal devices
4 secondary outcomes
Stage 1: The compliance of subjects with wearable devices
Time frame: 2 months
Stage 1: Association between the severity of COPD airflow restriction, CAT score, mMRC score, echocardiography, blood gas analysis, six-minutes walking distance, polysomnography，and data collected by wearable devices
Time frame: 2 months
Stage 2: Association between the severity of COPD airflow restriction, CAT score, mMRC score，and data collected by wearable devices
Time frame: 5 months
Stage 2: number of adverse events
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40093702Zhang C, Yu K, Jin Z, Bao Y, Zhang C, Liao J, Wang G. Intelligent wearable devices with audio collection capabilities to assess chronic obstructive pulmonary disease severity. Digit Health. 2025 Mar 13;11:20552076251320730. doi: 10.1177/20552076251320730. eCollection 2025 Jan-Dec.
- 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.
Guangfa Wang, MD study chair
Peking University First Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Peking University First Hospital at 10 sites 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stage 1: Association between the severity of COPD airflow restriction and data collected by wearable devices (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551169, which also lists 1 linked publication.
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 Jan 2024.