Tests voice and breath signals to detect emphysema in people with COPD
Tests whether voice and breath measurements can detect emphysema in adults with COPD.
Plain-language title generated from the registry record
Registry title: Exploring Novel Biomarkers for Emphysema Detection
Key facts
- Where
- Maastricht and Roermond, NetherlandsSee the 2 sites
Where in Netherlands
- Dept of Respiratory Medicine, Maastricht University Medical CentreMaastricht, NetherlandsTaking people
- Laurentius ZiekenhuisRoermond, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maastricht University
- Trial code
- NCT05825261
- Record updated
- 13 June 2025
- Original description
The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:Read full original descriptionShow less
Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study
The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
• Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and/or capnometry.
Participants will:
* perform different voice-related tasks * perform capnometry twice (before/after exercise) * perform a light exercise task between tasks ( 5-sit-to-stand test) * undergo one venipuncture
Inclusion: 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: participation in another study involving investigational products. Participation in observational studies is allowed; comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA< BMI > 40); comorbidities affecting speech characteristics of dyspnea (severe heart failure, interstitial lung disease); 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); acute exacerbation of COPD within 8 weeks of start of the study; comorbidities affecting respiratory system including but not exclusive to asthma or cystic fibrosis; inability to carry out a capnography recording; investigator's uncertainty about the willingness or ability of the patients to comply with the protocol requirements.