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)

Recruiting

• Conditions: Pulmonary Fibrosis; Chronic Obstructive Pulmonary Disease; Cystic Fibrosis
• Interventions: Other: Lung sound recordings

• Registration Number: NCT06399094
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Study Start: 2024-07-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary fibrosis	Lung sound recordings	-
Chronic Obstructive Pulmonary Disease	Lung sound recordings	-
Cystic fibrosis	Lung sound recordings	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hôpitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, Bas-Rhin, France

GHRMSA - Hôpital Emile Muller; 🇫🇷 Mulhouse, Haut-Rhin, France