Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02056860
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2014-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Lung Infections Through Vibration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2014-01-30', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal Operating Conditions for HFO Device', 'timeFrame': '6 months', 'description': 'Following informed consent procedures, participants will be randomly assigned (much like a flip of a coin) to one of four experimental groups in order to test the effects of various frequencies of HFO on the size and concentration of particles obtained from EB. Group 1 (n=30) will receive 10 minutes of HFO at 15 Hz. Group 2 (n=30) will receive an identical course of HFO with the frequency set at 30 Hz. Group 3 (n=30) will receive HFO at 60 Hz and Group 4 (n=30) at 100 Hz. Participants will be tested on two separate days in order to systematically vary HFO intensity. Once again, much like a flip of a coin, each participant will be randomly assigned to receive HFO at either a low (0.75 cmH2O) or high (1.25 cm H2O) intensity on HFO Day 1. Participants receiving low intensity HFO on Day 1 will receive high intensity HFO on Day 2, and vice versa. Between HFO Testing Day 1 and 2 there will be a washout period of at least 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Particle size and distribution from exhaled breath', 'timeFrame': 'One year', 'description': 'The exhaled air will be directed to a culturing media in place of the Sizer for collection of the droplets during two conditions: tidal breathing without oscillation (control) and tidal breathing with oscillation (experimental). The samples collected in the medium will later be cultured in a lab to determine the microbial species and their abundances. The purpose of Phase II experiments is to characterize the biological constituents produced from the oscillation enhanced sampling and contrast these constituents with those obtained during non-oscillation enhanced sampling. We hope to determine if the addition of oscillation increases the variety and abundance of microbial species able to be extracted from exhaled breath.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis'], 'conditions': ['Lung Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.', 'detailedDescription': 'This study has two phases. Once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air.\n\nIn phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy normal adults age 18 to 50 Individuals with cystic fibrosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-50\n\nExclusion Criteria:\n\n* History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)'}, 'identificationModule': {'nctId': 'NCT02056860', 'briefTitle': 'Detecting Lung Infections Through Vibration', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections', 'orgStudyIdInfo': {'id': '821-2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 will receive 15 Hz', 'description': 'Group 1 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 15 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 15 Hz at 1.25 cm.', 'interventionNames': ['Procedure: Group 1 will receive 15 Hz']}, {'label': 'Group 2 will receive 30 Hz', 'description': 'Group 2 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 30 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 30 Hz 1.25 cm.', 'interventionNames': ['Procedure: Group 2 will receive 30 Hz']}, {'label': 'Group 3 will receive 60 Hz', 'description': 'Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz 2 .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 60 Hz at 1.25 cm.', 'interventionNames': ['Procedure: Group 3 will receive 60 Hz']}, {'label': 'Group 4 will receive 100 Hz', 'description': 'Group 4 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 100 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 100 Hz at 1.25 cm.', 'interventionNames': ['Procedure: Group 4 will receive 100 Hz']}, {'label': 'Phase II Optimal Frequency', 'description': 'Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.', 'interventionNames': ['Procedure: Phase II Optimal Frequency']}], 'interventions': [{'name': 'Group 1 will receive 15 Hz', 'type': 'PROCEDURE', 'description': 'Group 1 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 15 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 15 Hz at 1.25 cm.', 'armGroupLabels': ['Group 1 will receive 15 Hz']}, {'name': 'Group 2 will receive 30 Hz', 'type': 'PROCEDURE', 'description': 'Group 2 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 30 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 30 Hz 1.25 cm.', 'armGroupLabels': ['Group 2 will receive 30 Hz']}, {'name': 'Group 3 will receive 60 Hz', 'type': 'PROCEDURE', 'description': 'Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 60 Hz at 1.25 cm.', 'armGroupLabels': ['Group 3 will receive 60 Hz']}, {'name': 'Group 4 will receive 100 Hz', 'type': 'PROCEDURE', 'description': 'Group 4 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 100 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 100 Hz at 1.25 cm.', 'armGroupLabels': ['Group 4 will receive 100 Hz']}, {'name': 'Phase II Optimal Frequency', 'type': 'PROCEDURE', 'description': 'Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.', 'armGroupLabels': ['Phase II Optimal Frequency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Erin P Silverman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Afshar-Mohajer N, Wu CY, Tsai HW, Silverman E, Davenport P, Hegde S. Optimizing an Internal Airway Percussion Device for Facilitating Exhalate Diagnostics of the Human Respiratory System. J Aerosol Med Pulm Drug Deliv. 2015 Mar 31. \\[Epub ahead of print\\] PubMed PMID: 25826647.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}