Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT06461195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group interventional study acquiring spirometry data, respiration sound and physiological data in patients suffering from pulmonary disease.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiration flow', 'timeFrame': '1 year', 'description': 'Measured in liter per minute, measured by a spirometer.'}, {'measure': 'Respiration volume', 'timeFrame': '1 year', 'description': 'Measured in liter, measured by a spirometer.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '1 year', 'description': 'Measured in beats per minute by photoplethysmography using a wrist watch with a sensor'}, {'measure': 'Skin conductivity', 'timeFrame': '1 year', 'description': 'Measured in Siemens using a wrist watch with a sensor'}, {'measure': 'Body temperature', 'timeFrame': '1 year', 'description': 'Measured in degrees Celsius using a wrist watch with a sensor'}, {'measure': 'Oxygen saturation', 'timeFrame': '1 year', 'description': 'Measured in percentage by photoplethysmography using a wrist watch with a sensor'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spirometry', 'Respiratory sounds'], 'conditions': ['Respiratory Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to collect data: audio in the form of respiratory sounds and instructions from the therapist, spirometry data during the execution of the therapy, physiological parameters, and patient information. With the help of this data, algorithms will be developed for the automatic detection, localization, and classification of respiratory sounds, linked to the respiratory cycle using spirometric signals.', 'detailedDescription': 'The study is an interventional study. Patients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physio-logical parameters.\n\nIt has been chosen to intervene as little as possible in the therapy to measure the respiratory sounds and breathing of the patient as accurately as possible. By recording therapy sessions with 15 patients, we expect to register several hundred events of respiratory sounds. This provides a good foundation for training an algorithm to detect and classify respiratory sounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has a chronic or acute respiratory condition and may need oxygen therapy\n* The patient is minimally 12 years old\n\nExclusion Criteria:\n\n* The patient is cognitively impaired.\n* The patient has an undrained pneumothorax.\n* The patient is experiencing an acute pulmonary hemorrhage.\n* The patient is having an asthma exacerbation.\n* The patient has an infection with Burkholderia cepatia.\n* The patient is in isolation due to the risk of infection.'}, 'identificationModule': {'nctId': 'NCT06461195', 'acronym': 'COMPASS', 'briefTitle': 'Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals', 'organization': {'class': 'OTHER', 'fullName': 'Thomas More Kempen'}, 'officialTitle': 'Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals', 'orgStudyIdInfo': {'id': '2023COMPASS-ST01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regular respiratory physiotherapy while being monitored', 'description': 'Patients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physiological parameters.', 'interventionNames': ['Other: Monitoring of patients']}], 'interventions': [{'name': 'Monitoring of patients', 'type': 'OTHER', 'description': 'Data from a spirometer and a stethoscope are captured to develop algorithms to detect and classify respiration sounds to support therapists and patients in future therapy.', 'armGroupLabels': ['Regular respiratory physiotherapy while being monitored']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kris Cuppens, PhD', 'role': 'CONTACT', 'email': 'kris.cuppens@thomasmore.be', 'phone': '+ 32 14 74 06 28'}, {'name': 'Filip Van Ginderdeuren, PhD', 'role': 'CONTACT', 'email': 'filip.vanginderdeuren@uzbrussel.be'}], 'overallOfficials': [{'name': 'Filip Van Ginderdeuren, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lieven De Maesschalck', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}, {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Innovation Manager', 'investigatorFullName': 'Lieven De Maesschalck', 'investigatorAffiliation': 'Thomas More Kempen'}}}}