Exploring Novel Biomarkers for Emphysema Detection

Launched by MAASTRICHT UNIVERSITY · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to detect emphysema, a serious lung condition, in people with chronic obstructive pulmonary disease (COPD). Researchers want to see if they can use voice recordings or a simple test that measures carbon dioxide levels in the breath (called capnometry) to help identify how severe emphysema is, using chest CT scans. They hope to develop a computer program that can analyze this information to provide better detection and understanding of the disease.

To participate in this study, you need to have a confirmed diagnosis of COPD and have had a chest CT scan in the last year. You should also be able to understand, read, and write in Dutch. Participants will perform various voice tasks, take capnometry tests before and after some light exercise, and have a small blood sample taken. This study is currently recruiting individuals aged 65 to 74, and it’s important to note that certain medical conditions may exclude you from participating. If you're interested, this trial could help improve how emphysema is detected and managed in the future.

Gender

ALL

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.