Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-26
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:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATFSPP
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 patients 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 patients 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 patients 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 patients 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:
None
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?:
None