RecruitingNCT05825261

Exploring Novel Biomarkers for Emphysema Detection

Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study


Sponsor

Maastricht University

Enrollment

200 participants

Start Date

Sep 7, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for new markers in speech and breathing patterns that could help detect emphysema (a type of lung damage) earlier and more accurately. Researchers will analyze speech recordings and breathing tests to see if they can identify signs of emphysema without invasive tests. **You may be eligible if...** - You are an adult over 18 years old - You have current breathing symptoms such as shortness of breath, cough, or mucus production - You have confirmed airflow obstruction on a breathing test or emphysema signs on a CT scan - You have risk factors for COPD (such as a history of smoking) - You have had a chest CT scan within the past 12 months - You can read, write, and understand Dutch **You may NOT be eligible if...** - You had a COPD flare-up in the past 8 weeks - You have conditions that affect speech or breathing (e.g., severe heart failure, Parkinson's disease, neuromuscular disease, BMI over 40) - You have asthma or cystic fibrosis - You have had part of a lung surgically removed or had a lung volume reduction procedure - You are participating in another interventional study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERvoice sampling

Patients with COPD will perform several voice-related tasks and capnometry at rest. Thereafter a 5-STS will follow and the voice-related task/capnometry will be repeated

OTHERcapnometry

Patients with COPD will perform several voice-related tasks and capnometry at rest. Thereafter a 5-STS will follow and the voice-related task/capnometry will be repeated


Locations(2)

Dept of Respiratory Medicine, Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Laurentius Ziekenhuis

Roermond, Limburg, Netherlands

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NCT05825261


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