Using voice and breathing tests to detect emphysema in COPD patients

Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study

This study is testing whether voice and breathing tests can help find out how severe emphysema is in people with COPD.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maastricht University (other)
• Locations: 2 sites (Maastricht, Limburg and 1 other locations)
• Trial ID: NCT05825261 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of vocal biomarkers and capnometry in detecting emphysema in patients with chronic obstructive pulmonary disease (COPD). Participants will perform various voice-related tasks and undergo capnometry measurements before and after a light exercise task. The study will utilize machine learning algorithms to classify the extent of emphysema based on these non-invasive biomarkers in conjunction with chest CT scans. The goal is to develop a reliable method for identifying emphysema severity using innovative techniques.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with COPD who have undergone a chest CT scan within the last 12 months and can communicate in Dutch.

Not a fit: Patients experiencing acute exacerbations of COPD or those with comorbidities affecting speech or breathing coordination may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of emphysema, improving patient management and outcomes.

How similar studies have performed: While the use of machine learning in medical diagnostics is growing, this specific approach combining vocal biomarkers and capnometry for emphysema detection is relatively novel and has not been extensively tested.

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.

Where this trial is running

Maastricht, Limburg and 1 other locations

• Dept of Respiratory Medicine, Maastricht University Medical Centre — Maastricht, Limburg, Netherlands (RECRUITING)
• Laurentius Ziekenhuis — Roermond, Limburg, Netherlands (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Sami Simons, MD PhD — Maastricht University
• Study coordinator: Sami Simons, MD PhD

Conditions: Copd, Emphysema, vocal biomarkers, speech, emphysema, capnometry, chest CT