Actively Recruiting
Exploring Novel Biomarkers for Emphysema Detection
Led by Maastricht University · Updated on 2025-06-13
200
Participants Needed
2
Research Sites
138 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
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
CONDITIONS
Official 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 emphysema abnormalities on CT imaging
- Presence of risk factors or causes associated with COPD
- Chest CT scan performed within 12 months prior to study inclusion
- Ability to understand, read, and write Dutch
You will not qualify if you...
- Acute COPD exacerbation within 8 weeks before the study
- Comorbidities affecting speech or breathing coordination (neuromuscular disease, stroke, BMI > 40)
- Comorbidities affecting speech or dyspnea characteristics (severe heart failure, interstitial lung disease)
- Respiratory system comorbidities including asthma or cystic fibrosis
- Conditions interfering with speech interpretation such as Parkinson's disease, bulbar palsy, or vocal cord paralysis
- History of lung surgery such as lobectomy or endoscopic lung volume reduction
- Inability to complete capnography recording
- Investigator doubts about willingness or ability to comply with study protocol
- Participation in other studies involving investigational products (observational studies allowed)
AI-Screening
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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
CONTACT
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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