Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT05085795
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2021-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Deep Breathing in Health Participants Using a Device Called Impulse Oscillometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009058', 'term': 'Mouth Breathing'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-14', 'size': 159590, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-08T17:07', 'hasProtocol': True}, {'date': '2022-02-15', 'size': 159428, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-08T17:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean respiratory system impedance', 'timeFrame': 'pre deep inspiration, approximately day 1', 'description': 'The oscillometer will collect an airway impedance measurement which is made up of multiple variables.'}, {'measure': 'Mean respiratory system resistance', 'timeFrame': 'post deep inspiration, approximately day 1', 'description': 'The oscillometer will collect an airway impedance measurement which is made up of multiple variables.'}, {'measure': 'Mean change in respiratory system resistance', 'timeFrame': 'post and pre deep inspiration, approximately day 1', 'description': 'The oscillometer will collect an airway impedance measurement which is made up of multiple variables.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breathing, Mouth', 'Lung Function Decreased']}, 'descriptionModule': {'briefSummary': 'This study will determine if resistance of the airway to airflow and pressure, measured by Impulse Oscillometry, is impacted by a deep breathe maneuver in a small cohort of healthy human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Up to fifty (50) healthy subjects will be recruited from Mary Parkes Asthma and Allergy Center and the outpatient pulmonary clinics at the University of Rochester Medical Center, and from the Pulmonary and Critical Care Division at the University of Rochester', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaccinated against COVID-19\n* Ability to provide informed consent\n* Willingness to perform breathing test\n* Willingness to provide basic demographic data\n* Must be able to speak and understand English\n\nExclusion Criteria:\n\n* Unable to or unwilling to provide consent, perform test, or provide basic demographic data'}, 'identificationModule': {'nctId': 'NCT05085795', 'briefTitle': 'Evaluating Deep Breathing in Health Participants Using a Device Called Impulse Oscillometry', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Impulse Oscillometry and the Bronchoprotective Effects of Deep Inspiration', 'orgStudyIdInfo': {'id': 'STUDY00006488'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'interventionNames': ['Device: Impulse Oscillometer']}], 'interventions': [{'name': 'Impulse Oscillometer', 'type': 'DEVICE', 'otherNames': ['THORASYS tremoFlo C-100 Airwave Oscillometry System'], 'description': 'The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Mary Parkes Asthma and Allergy Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steve Nicholas Georas', 'investigatorAffiliation': 'University of Rochester'}}}}