COPD emphysema
Conditions
Interventions
None listed
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adults aged over 18 years - current respiratory symptoms (any dyspnea, cough, or sputum) - Spirometry-confirmed diagnosis of a non-fully reversible airflow obstruction (defined as postbronchodilator FEV1/FVC
Exclusion criteria
Exclusion criteria: - acute exacerbation of COPD within 8 weeks of start of the study - comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA) - 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. - 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. - Medical history of lobectomy or Endoscopic Long Volume Redcution (ELVR) - BMI > 40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether voice or capnometry, alone or in combination with other (non-invasive) biomarkers, can be used to classify emphysema predominant COPD phenotype (>=25% emphysematous lung tissue). Study endpoints are: Emphysema quantification (25% of voxels below *950HU on a HRCT scan), Voice characteristics (see table 1), Capnometry (end-tidal CO2, Slp2 and Slp3) and Emphysema Severity Index (FEF25, FEF25, FEF75) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate if adding a blood biomarkers for emphysema (sRAGE) increases the diagnostic accuracy of the classification model (= 25% emphysema)for detecting emphysema phenotype COPD (>= 25% emphysema). Study endpoints are: Emphysema quantification (25% of voxels below *950HU on a HRCT scan), Voice characteristics (see table 1), Capnometry (end-tidal CO2, Slp2 and Slp3) and Emphysema Severity Index (FEF25, FEF25, FEF75) , blood (sRAGE) - To evaluate which lung function parameters increase the accuracy of the classification model (= 25% emphysema). Outcomes: Emphysema quantification: 25% percentage of voxels below *950HU on a HRCT scan. Study endpoints are: Emphysema quantification (25% of voxels below *950HU on a HRCT scan), Voice characteristics (see table 1), Capnometry (end-tidal CO2, Slp2 and Slp3) and Emphysema Severity Index (FEF25, FEF25, FEF75) , blood (sRAGE), lung function: FEV1, FVC, FEV/FVC, TLC, FRC, RV, FRC/TLC, RV/TLC, TLCO, - To evaluate if specific features extracted from speech are associated with the percentage of emphysema on a chest CT scan from patients with COPD. Endpoints are: Emphysema quantification (Percentage of voxels below *950HU on a HRCT scan (range 0-100%)), voice features (see table 1) - To evaluate if specific features extracted from the capnogram are associated with the percentage of emphysema on a chest CT scan from patients with COPD. Endpoints are: Emphysema quantification (Percentage of voxels below *950HU on a HRCT scan (range 0-100%)), Capnometry (End-tidal CO2, Slp2 and Slp3). | — |
Countries
Netherlands
Outcome results
None listed