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, we have established an algorithm that can detect and infer the severity of COPD from physiological parameters and audio data collected by wearable devices, and in this stage, we aim to evaluate the accuracy of this algorithm.

Trial Health

On Track

Trial Health Score

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

Enrollment

400

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2022

Geographic Reach

1 country

5 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

September 13, 2022

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed

Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

October 25, 2023

Last Update Submit

January 20, 2024

Conditions

COPD

Keywords

COPDIntelligent Terminal DeviceAlgorithm model

Outcome Measures

Primary Outcomes (1)

The diagnostic accuracy of the algorithm for COPD
The diagnostic accuracy of the algorithm for COPD
1 year

Secondary Outcomes (2)

The diagnostic sensitivity and specificity of the algorithm
1 year
The diagnostic accuracy of COPD-PS score for COPD
1 year

Study Arms (1)

Participants with high risk of COPD

no intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

participants at high risk of COPD

You may qualify if:

Over the age of 18, no gender restrictions.
Participants at high risk of COPD (COPD-PS score ≥5).
Able to carry out daily activities and wear wearable devices.
Willing to participate in the study, willing to comply with the study protocol, and have the ability to sign informed consent.
Possess mobile communication equipment, which can meet the requirement of installing wearable device applications and recording function.

You may not qualify if:

Diagnosed with chronic respiratory diseases other than COPD, such as 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 \> 3 times the upper limit of normal), heart failure (NYHA\> Grade 3), autoimmune disease, chronic kidney disease (CKD-5), unstable coronary artery disease, arrhythmia (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, inability to wear a watch/bracelet due to incomplete skin.
Dual upper limb pigmentation or abnormal blood supply (occlusion, thrombosis, trauma, etc.).

Contact the study team to confirm eligibility.