Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-28 @ 5:47 AM
Study NCT ID:
NCT06232356
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Lung Health by a Mobile Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-01-28', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main Outcome', 'timeFrame': 'At the time of assessment', 'description': 'Proportion of lung function abnormalities (defined as FEV1/FVC\\<0.7 or LLN) detected with the mobile app'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': 'At the time of assessment', 'description': 'To analize the diagnostic performance from web app to detect different lung function abnormalities'}, {'measure': 'Secondary Outcome', 'timeFrame': 'At the time of assessment', 'description': 'To evaluate concordancy between lung function estimates obtained with a mobile app and spirometers'}, {'measure': 'Secondary Outcome', 'timeFrame': 'At the time of assessment', 'description': 'Proportion of lung function abnormalities (defined as FVC \\<80% predicted or LLN) detected with the mobile app'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spirometry'], 'conditions': ['Lung Diseases', 'COPD']}, 'descriptionModule': {'briefSummary': 'Respiratory diseases are a common cause of mortality and disability at the worldwide and national levels. Many of them are characterized by underdiagnosis and diagnosis in advanced stages of the disease, and in most of them, forced spirometry is one of the fundamental tools to assess the diagnosis and seriousness of the disease.\n\nTo help in improving the detection of respiratory diseases and the understanding of the respiratory health of the general population, one possible solution would be to develop a mobile application that could assess respiratory health by using the sound signal of exhaled air recorded by a mobile microphone.\n\nThis project will aim to validate a mobile application (WebApp) for the detection of pulmonary function disorders. It is planned to recruit 267 subjects, with and without respiratory disease, who are attended in pulmonary function laboratories of 10 Spanish hospitals, to compare the sensitivity of this application in the diagnosis of pulmonary function disorders (either obstructive patterns or PRISm) versus the gold standard (spirometry). Ease of use and user satisfaction with the application will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of adult subjects (healthy or with respiratory disease - COPD) between 18 and 80 years of age, who will be enrolled in the pulmonary function laboratories of the participating hospitals, from among those listed above, who are attended to a functional respiratory examination.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects with age range between 18 and 80 years old\n* Signing the informed consent form\n* Subjects scheduled for respiratory function tests at the pulmonary function laboratory for clinical reasons\n* Having a cell phone and be willing to install the application\n\nExclusion Criteria:\n\n* Contraindication to perform any of the protocol procedures\n* Inability to answer the study questionnaires.'}, 'identificationModule': {'nctId': 'NCT06232356', 'acronym': 'SMILE', 'briefTitle': 'Screening for Lung Health by a Mobile Device', 'organization': {'class': 'OTHER', 'fullName': 'SEPAR- EPOC'}, 'officialTitle': 'Respiratory Health Screening Using a Mobile Device', 'orgStudyIdInfo': {'id': 'SAP_SMILE_2864995'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study population', 'description': 'The study population will consist of adult subjects (healthy or with respiratory disease - COPD) between 18 and 80 years of age, who will be enrolled in the pulmonary function laboratories of the participating hospitals, from among those listed above, who are attended to a functional respiratory examination.', 'interventionNames': ['Diagnostic Test: Mobile Web App']}], 'interventions': [{'name': 'Mobile Web App', 'type': 'DIAGNOSTIC_TEST', 'description': "all participants will undergo an assessment of respiratory health by analyzing the sound of exhaled air recorded by the participant's mobile phone", 'armGroupLabels': ['Study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18014', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Bernardino Alcázar', 'role': 'CONTACT', 'email': 'bernardino.alcazar.sspa@juntadeandalucia.es', 'phone': '958020127'}], 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco García Rio', 'role': 'CONTACT', 'email': 'bernardino.alcazar.sspa@juntadeandalucia.es', 'phone': '958020127'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SEPAR- EPOC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}