Frequency-time Analysis of Pathological Lung Sounds: Detection and Quantification of Pathological Sounds in Patients With Cystic Fibrosis, Pulmonary Fibrosis or COPD (Chronic Obstructive Pulmonary Disease) (ATF/SPP)

The main objective of the study is to assess the potential of time-frequency representation and analysis of pulmonary sounds collected with an electronic stethoscope, as part of the routine monitoring of patients with cystic fibrosis, COPD or pulmonary fibrosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Fibrosis; Cystic Fibrosis
• Intervention / Treatment: Other: Lung sound recordings

Detailed Description

Secondary objectives

The other objectives of this study are :

1. To evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation.
2. To evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method.

Conduct of research This is a single-center, non-randomized, open-label study involving 60 male and female patients aged 18 to 65, eligible for a scheduled consultation as part of their usual pathological follow-up (routine care).

Lung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition.

Recordings will be made using a 3M Littmann© model 3200 electronic stethoscope. The stethoscope works with Eko software, which will be installed on a touch-sensitive tablet or computer, enabling local storage of recorded data.

Whatever the patient's pathology, the physician will listen to 10 lung sites defined in the protocol. At least one breath per pulmonary site will be recorded during the consultation.

If a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed.

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be recruited during a consultation scheduled as part of the usual follow-up of their pathology in the pneumology department of mulhouse hospital center and strasbourg university hospital center.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, COPD
• Not opposed to participating in the study

Exclusion Criteria:

• Person under court protection, guardianship or curatorship
• Person deprived of liberty by judicial or administrative decision
• Patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Obstructive Pulmonary Disease	Other: Lung sound recordings; The lung sound recordings will be made during a consultation scheduled as part of the patient's usual follow-up, after obtaining the patient's non-opposition.
Cystic fibrosis	Other: Lung sound recordings; The lung sound recordings will be made during a consultation scheduled as part of the patient's usual follow-up, after obtaining the patient's non-opposition.
Pulmonary fibrosis	Other: Lung sound recordings; The lung sound recordings will be made during a consultation scheduled as part of the patient's usual follow-up, after obtaining the patient's non-opposition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung sounds visible in their representation as time-frequency images	Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of sounds by severity	Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.	At inclusion

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Estimated): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Signs and Symptoms, Respiratory; Pancreatic Diseases; Lung Diseases, Interstitial; Chronic Disease; Fibrosis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Cystic Fibrosis; Respiratory Sounds
• Other Study ID Numbers: GHRMSA 1315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No