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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT05655832
Eligibility Criteria:
Inclusion Criteria:
For participants with COPD:
* Participants ≥40 and ≤80 years at baseline
* Diagnosis of COPD stage II to IV
* History of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures)
For participants in the calibration cohort:
• Participants ≥40 and ≤80 years at baseline
Exclusion Criteria:
For participants with COPD:
* Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia \[esp. atrial fibrillation and conduction blocks\]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study
* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
* Participants with known allergies or sensitivity to silicon or hydrogel
* Less than 6 weeks since previous moderate/severe exacerbation
For participants in the calibration cohort:
* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
* Participants with known allergies or sensitivity to silicon or hydrogel
* Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05655832
Study Brief:
Protocol Section:
NCT05655832