Actively Recruiting

Age: 18Years +
All Genders
NCT05825261

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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