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

COPD Emphysema

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

Inclusion Criteria6

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 Criteria9

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.

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