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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT05825261
Eligibility Criteria:
Inclusion Criteria:
* Adults aged over 18 years
* current respiratory smptoms (any dyspnea, cough or sputum)
* spirometry confirmed diagnosis of a non-fully reversible airflow obstruction, defined as a post bronchodilator Forced Expiratory Volume at one second/Forced Vital Capacity (FEV1/FVC ratio) \< 0.7 and/or emphysemateus abnormalities on CT imaging.
* presence of risk factors or causes associated with COPD
* chest CT scan performed in the past 12 months prior to inclusion to the study
* able to understand, read and write Dutch language
Exclusion Criteria:
* acute exacerbation of COPD within 8 weeks of start of the study
* comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA\< BMI \> 40)
* comorbidities affecting speech characteristics of dyspnea (severe heart failure, interstitial lung disease)
* comorbidities affecting respiratory system including but not exclusive to asthma or cystic fibrosis
* comorbidities that significantly interfere with interpretation of speech (audio signals), such as Parkinson's disease, bulbar palsy, or vocal cord paralysis.
* Medical history of lobectomy or endoscopic lung volume reduction (ELVR)
* inability to carry out a capnography recording.
* investigator's uncertainty about the willingness or ability of the patients to comply with the protocol requirements.
* participation in another study involving investigational products. Participation in observational studies is allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05825261
Study Brief:
Protocol Section:
NCT05825261