Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT06399094
Status:
TERMINATED
Last Update Posted:
2025-11-17
First Post:
2024-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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)
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATF/SPP
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: