NCT05825261 Exploring Novel Biomarkers for Emphysema Detection
| NCT ID | NCT05825261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University |
| Condition | Copd |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-09-07 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-09-07 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Contact & Investigator
Sami Simons, MD PhD
PRINCIPAL INVESTIGATOR
Maastricht University
Frequently Asked Questions
Who can join the NCT05825261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Copd. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05825261 currently recruiting?
Yes, NCT05825261 is actively recruiting participants. Contact the research team at sami.simons@mumc.nl for enrollment information.
Where is the NCT05825261 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Roermond, Netherlands.
Who is sponsoring the NCT05825261 clinical trial?
NCT05825261 is sponsored by Maastricht University. The principal investigator is Sami Simons, MD PhD at Maastricht University. The trial plans to enroll 200 participants.
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