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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment issue', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung sounds visible in their representation as time-frequency images', 'timeFrame': 'At inclusion', 'description': 'Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.'}], 'secondaryOutcomes': [{'measure': 'Classification of sounds by severity', 'timeFrame': 'At inclusion', 'description': 'Pulmonary sounds will be recorded with an electronic stethoscope at each scheduled visit and processed with artificial intelligence using a supervised learning method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis', 'Chronic Obstructive Pulmonary Disease', 'Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Secondary objectives\n\nThe other objectives of this study are :\n\n1. To evaluate the ability to detect changes in lung sounds, following optimization of the time-frequency representation.\n2. To evaluate the ability to quantify differences in the severity of the pathological sounds detected using artificial intelligence and a supervised learning method.\n\nConduct 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).\n\nLung sound recordings will be made during the same consultation, after obtaining the patient's non-opposition.\n\nRecordings 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.\n\nWhatever 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.\n\nIf a patient comes back for a consultation before the end of the recruitment period, a new lung sound recording will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Suffering from one of the following pathologies: cystic fibrosis, pulmonary fibrosis, COPD\n* Not opposed to participating in the study\n\nExclusion Criteria:\n\n* Person under court protection, guardianship or curatorship\n* Person deprived of liberty by judicial or administrative decision\n* Patient with a history of thoracic surgery, thoracic deformity, heart failure or other relevant illness at the investigator's discretion."}, 'identificationModule': {'nctId': 'NCT06399094', 'acronym': 'ATF/SPP', 'briefTitle': '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)', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'GHRMSA 1315'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary fibrosis', 'interventionNames': ['Other: Lung sound recordings']}, {'label': 'Chronic Obstructive Pulmonary Disease', 'interventionNames': ['Other: Lung sound recordings']}, {'label': 'Cystic fibrosis', 'interventionNames': ['Other: Lung sound recordings']}], 'interventions': [{'name': 'Lung sound recordings', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Chronic Obstructive Pulmonary Disease', 'Cystic fibrosis', 'Pulmonary fibrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'state': 'Bas-Rhin', 'country': 'France', 'facility': 'Hôpitaux Universitaire de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '68100', 'city': 'Mulhouse', 'state': 'Haut-Rhin', 'country': 'France', 'facility': 'GHRMSA - Hôpital Emile Muller', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}