Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05551169
Eligibility Criteria:
Stage 1:
Inclusion criteria:
1. Older than 18 years old, no gender limitation;
2. In COPD stable stage (if there is an acute exacerbation, patients should be enrolled 3 months after remission of the exacerbation);
3. Be able to carry out daily activities and wear wearable devices;
4. Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
5. Possess mobile communication equipment, which can meet the requirement of installing wearable device APP, and have a recording function.
Exclusion criteria:
1. 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.);
2. lobectomy and/or lung transplantation, pleural disease;
3. 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;
4. Malnutrition (BMI\<18 kg/m2);
5. Bilateral wrist and hand edema, wrist soft tissue injury, can not wear a watch/bracelet because of the incompleted skin;
6. 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;
Inclusion criteria:
1. Older than 18 years old;
2. Be able to carry out daily activities and wear wearable devices;
3. Have willing to participate in this study and comply with the study protocol, and can sign informed consent;
4. 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05551169
Study Brief:
Protocol Section:
NCT05551169