Brief 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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

432

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2022

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

June 21, 2022

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed

Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

September 17, 2022

Last Update Submit

January 2, 2024

Conditions

COPD

Keywords

COPDIntelligent Terminal DeviceAlgorithm model

Outcome Measures

Primary Outcomes (2)

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
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
5 months

Secondary Outcomes (4)

Stage 1: The compliance of subjects with wearable devices
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
2 months
Stage 2: Association between the severity of COPD airflow restriction, CAT score, mMRC score，and data collected by wearable devices
5 months
Stage 2: number of adverse events
5 months

Study Arms (3)

Patients with stable COPD in Stage1

no intervention

Patients with stable COPD in Stage2

no intervention

Non-COPD subjects in Stage2

no intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Stage I: patients with stable COPD Stage 2: patients with stable COPD and non-COPD subjects

You may qualify if:

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.

You may not qualify if:

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;
Older than 18 years old;
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.

Contact the study team to confirm eligibility.