Deep Learning Diagnostic and Risk-stratification for IPF and COPD
NCT ID: NCT05318599
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
160 participants
OBSERVATIONAL
2023-04-01
2024-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Artificial intelligence (AI)-assisted digital lung auscultation could constitute an alternative to conventional subjective operator-related auscultation to accurately and earlier diagnose these diseases. Moreover, lung ultrasound (LUS), a relevant gold standard for lung pathology, could also benefit from automation by deep learning.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Severity Assessment Model for AECOPD With Combination of Disease and Syndrome
NCT06918353
Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)
NCT05998512
A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
NCT03261037
Segmentation of Structural Abnormalities in Chronic Lung Diseases
NCT04760548
Detect and Infer the Severity of COPD by Intelligent Terminal Device
NCT05551169
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Methodology: A single-center, prospective, population-based case-control study that will be carried out in subjects with IPF, NSIP and COPD. A total of 120 consecutive patients aged ≥ 18 years and meeting IPF, NSIP or COPD international criteria, and 40 age-matched controls, will be recruited in a Swiss pulmonology outpatient clinic with a total of approximately 7000 specialized consultations per year, starting from August 2022.
At inclusion, demographic and clinical data will be collected. Additionally, lung auscultation will be recorded with a digital stethoscope and LUS performed. A deep learning algorithm (DeepBreath) using various deep learning networks with aggregation strategies will be trained on these audio recordings and lung images to derive an automated prediction of diagnostic (i.e., positive vs negative) and risk stratification categories (mild to severe).
Secondary outcomes will be to measures the association of analysed lung sounds with clinical, functional and radiological characteristics of IPF, NSIP and COPD diagnosis. Patients' quality of life will be measured with the standardized dedicated King's Brief Interstitial Lung Disease (K-BILD) and the COPD assessment test (CAT) questionnaires.
Expected results: This study seeks to explore the synergistic value of several point-of-care-tests for the detection and differential diagnosis of ILD and COPD as well as estimate severity to better guide care management in adults
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IPF patients (group 1)
Consenting adult patients \>18 years old with with already-diagnosed IPF
Lung auscultation
Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).
Lung ultrasound
Lung ultrasonography
Quality of Life's questionnaires
Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)
Pulmonary functional tests
Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.
NSIP patients (group 2)
Consenting adult patients \>18 years old with with already-diagnosed non-specific interstitial pneumonia (NSIP)
Lung auscultation
Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).
Lung ultrasound
Lung ultrasonography
Quality of Life's questionnaires
Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)
Pulmonary functional tests
Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.
COPD patients (group 3)
Consenting adult patients \>18 years old with with already-diagnosed chronic obstructive pulmonary disease (COPD)
Lung auscultation
Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).
Lung ultrasound
Lung ultrasonography
Quality of Life's questionnaires
Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)
Pulmonary functional tests
Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.
Control subjects (group 4)
Consenting age-matched (+/- 2.5 years) never smokers patients with normal lung function (spirometry, lung volume and Transfer Factor for Carbon Monoxide (TLCO)) followed in the pulmonology outpatient clinic with similar quality of electronic medical records but for diseases other than the outcome of interest, namely:
1. patients with obstructive sleep apnea.
2. patients followed-up for occupational lung diseases (miners, chemical workers, etc.).
3. patients followed-up for pulmonary nodules (considered benign after 2 years).
Lung auscultation
Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).
Lung ultrasound
Lung ultrasonography
Quality of Life's questionnaires
Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)
Pulmonary functional tests
Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lung auscultation
Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).
Lung ultrasound
Lung ultrasonography
Quality of Life's questionnaires
Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)
Pulmonary functional tests
Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age \> 18 years old.
* patients with already-diagnosed IPF (group 1) prior to the consultation (index) date.
* patients with already-diagnosed NSIP (group 2) prior to the consultation (index) date.
* patients with already-diagnosed COPD (group 3) prior to the consultation (index) date.
* Control subjects must be followed-up at the pulmonology outpatient clinic for:
1. obstructive sleep apnoea.
2. occupational lung diseases (miners, chemical workers, etc.).
3. pulmonary nodules (considered benign after 2 years).
Exclusion Criteria
* patients known for severe cardiovascular disease with pulmonary repercussion.
* patients known for a concurrent, acute, infectious pulmonary disease (e.g., pneumonia, bronchitis).
* patients known for asthma.
* patients known or suspected of immunodeficiency, alpha-1-antitrypsin deficit, and or under immunotherapy.
* patients with physical inability to follow procedures.
* patients with inability to give informed consent.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Geneva
OTHER
Swiss Federal Institute of Technology
OTHER
Hôpital du Valais
OTHER
Pediatric Clinical Research Platform
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre-Olivier Bridevaux, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hôpital du Valais, Switzerland
Johan N. Siebert, MD
Role: STUDY_DIRECTOR
Geneva University Hospitals, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier du Valais Romand
Sion, Valais, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Siebert JN, Hartley MA, Courvoisier DS, Salamin M, Robotham L, Doenz J, Barazzone-Argiroffo C, Gervaix A, Bridevaux PO. Deep learning diagnostic and severity-stratification for interstitial lung diseases and chronic obstructive pulmonary disease in digital lung auscultations and ultrasonography: clinical protocol for an observational case-control study. BMC Pulm Med. 2023 Jun 2;23(1):191. doi: 10.1186/s12890-022-02255-w.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IPFoscope
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.