Actively Recruiting
Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study
Led by Maastricht University · Updated on 2025-06-13
200
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Maastricht University
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether voice recordings or capnometry measurements, alone or combined with other non-invasive biomarkers, can detect emphysema on chest CT scans in people with chronic obstructive pulmonary disease (COPD). The study aims to develop a machine-learning algorithm to classify the extent of emphysema using features from speech and capnometry data. This research is observational and focuses on patients diagnosed with COPD with related respiratory symptoms and CT imaging results. Participants will perform various voice tasks such as paced reading, sustained vowels, coughing, and quiet breathing. Capnometry measurements will be taken before and after a light exercise task, specifically the 5-sit-to-stand test. These procedures will be done in a single clinic visit. Clinical data including lung function tests and CT scans are already collected as part of routine care. The study will analyze voice and capnometry data using machine learning models to classify emphysema severity. During the visit, participants will complete voice-related tasks and capnometry tests, perform a short exercise, and have blood drawn. Researchers will measure outcomes including emphysema extent on CT scans, various voice features, and capnography parameters. Additional lung function measures and serum biomarkers will also be reviewed. The study monitors data quality and uses statistical models to explore how well these non-invasive measures predict emphysema. Participation involves a single visit with no intervention treatment.
CONDITIONS
Brief Title
Exploring Novel Biomarkers for Emphysema Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years
- Current respiratory symptoms such as dyspnea, cough, or sputum
- Spirometry confirmed diagnosis of non-fully reversible airflow obstruction (FEV1/FVC ratio < 0.7) and/or emphysematous abnormalities on CT imaging
- Presence of risk factors or causes associated with COPD
- Chest CT scan performed within the past 12 months prior to the study
- Ability to understand, read, and write Dutch language
You will not qualify if you...
- Acute exacerbation of COPD within 8 weeks before the study
- Comorbidities affecting speech or breathing coordination (e.g., neuromuscular disease, stroke, BMI > 40)
- Comorbidities affecting speech characteristics or dyspnea (e.g., severe heart failure, interstitial lung disease)
- Comorbidities affecting the respiratory system such as asthma or cystic fibrosis
- Conditions interfering with speech interpretation like Parkinson's disease, bulbar palsy, or vocal cord paralysis
- History of lobectomy or endoscopic lung volume reduction
- Inability to perform capnography recording
- Uncertainty about willingness or ability to comply with study protocol
- Participation in other studies involving investigational products (observational studies allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit
Participants perform voice-related tasks and capnometry measurements before and after a light exercise task. Clinical characterization including pulmonary function tests and CT scans are reviewed as part of routine care.
1 visit (in-person)
Duration - Data analysis ongoing after measurements
Participants' speech features and capnometry data are evaluated to explore biomarkers for emphysema detection using machine learning models.
No additional visits required
Trial Site Locations
Total: 2 locations
1
Dept of Respiratory Medicine, Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Actively Recruiting
2
Laurentius Ziekenhuis
Roermond, Limburg, Netherlands, 6043 CV
Not Yet Recruiting
Research Team
S
Sami Simons, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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