Clinical trial NCT06399094: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Fibrosis
Chronic Obstructive Pulmonary Disease
Cystic Fibrosis
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lung sounds visible in their representation as time-frequency images
timeFrame: At inclusion
Secondary outcomes:
measure: Classification of sounds by severity
timeFrame: At inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaire de Strasbourg
state: Bas-Rhin
city: Mulhouse
country: France
facility: GHRMSA - Hôpital Emile Muller
state: Haut-Rhin
Study officials:
References: