NCT05825261

Exploring Novel Biomarkers for Emphysema Detection

Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Maastricht University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a cross sectional, single center study. At the clinic, patients with COPD will be invited to perform several voice related tasks (paced reading, sustained vowels, cough, quiet breathing) and will be instructed to perform capnometry measurements. These measurements will be performed before and after a light exercise task (5-STS: 5-sit-to-stand test). Clinical characterisation of patients including pulmonary function tests (spirometry, body plethysmography, diffusion capacity) and CT scans have been performed in all patients as a part of routine workup in the COPD care pathway. Emphysema will be quantified as low attenuation areas with a density below -950 Hounsfield units (HU) using Syngovia (Siemens, Erlangen, Germany). The primary outcome will fit a simple machine learning classification model (e.g. using logistic regression, support vector machines, random forests and/or decision tree) to classify logistic regression model for the outcome of emphysema (\>25% vs ≤ 25%) from speech features and capnometry. with explanatory variables of speech features. Similar classification methods with incremental models using capnography features will be explored. Prior to carrying out the above analyses, data has to be pre-processed, including merging data, quality control, handling of missing data and feature extraction.

Conditions

• Copd
• Emphysema

Interventions

Type	Name	Description
OTHER	voice 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
OTHER	capnometry	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

Timeline

• Start date: 2023-09-07
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2023-04-24
• Last updated: 2025-06-13

Locations

2 sites across 1 country: Netherlands