NCT05825261Recruiting
Exploring Novel Biomarkers for Emphysema Detection
Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 9 Mar 2023
- Start date
- 7 Sept 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Maastricht University
- Diseases
- COPD
- NCT number
- NCT05825261
What you commit to
- Study type: Observational
- Planned participants: 200
- From 7 Sept 2023 to the primary completion date, Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participation in another study involving investigational products. Participation in observational studies is allowed.
Other illness
- 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)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept of Respiratory Medicine, Maastricht University Medical Centre Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Laurentius Ziekenhuis Coordinator of this site? Confirm its status | Roermond | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.