Using voice and breathing tests to detect emphysema in COPD patients
Official title: Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study
Run by Maastricht University · NCT05825261 · Data updated 2026-11-12
This study is testing whether voice and breathing tests can help find out how severe emphysema is in people with COPD.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Maastricht University Academic / other |
| Locations | 2 sites (Maastricht, Limburg and 1 other locations) |
| Status | Recruiting |
| Started | September 7, 2023 |
| Main results expected | December 2025 |
| Study ends | May 2026 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT05825261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with COPD who have undergone a chest CT scan within the last 12 months and can communicate in Dutch.
✕Probably not a fit
Patients experiencing acute exacerbations of COPD or those with comorbidities affecting speech or breathing coordination may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of vocal biomarkers and capnometry in detecting emphysema in patients with chronic obstructive pulmonary disease (COPD). Participants will perform various voice-related tasks and undergo capnometry measurements before and after a light exercise task. The study will utilize machine learning algorithms to classify the extent of emphysema based on these non-invasive biomarkers in conjunction with chest CT scans. The goal is to develop a reliable method for identifying emphysema severity using innovative techniques.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of emphysema, improving patient management and outcomes.
How similar studies have gone: While the use of machine learning in medical diagnostics is growing, this specific approach combining vocal biomarkers and capnometry for emphysema detection is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Dept of Respiratory Medicine, Maastricht University Medical Centre
Maastricht, Limburg, Netherlands Recruiting -
Laurentius Ziekenhuis
Roermond, Limburg, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Sami Simons, MD PhD — Maastricht University
- Study coordinator: Sami Simons, MD PhD
- Email: sami.simons@mumc.nl
- Phone: +31 043 3876543
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.