Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT03906968
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2019-03-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Safety and Efficacy of a SinuSonic Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'solerz@musc.edu', 'phone': '(843) 792-3531', 'title': 'Dr. Zachary M. Soler', 'organization': 'MUSC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'This is a minimal risk study based on a commercially available device.', 'eventGroups': [{'id': 'EG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks', 'description': 'Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Peak Nasal Inspiratory Flow Test (PNIF Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'classes': [{'categories': [{'measurements': [{'value': '104.5', 'spread': '41.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks', 'description': 'Change from baseline to week 2 in subject nasal airway obstruction, as measure by the Peak Nasal Inspiratory Flow Test (PNIF Test). The PNIF is used to diagnose the patency of the nose.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '12.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks', 'description': 'Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visual Analog Scale (VAS) score at 4 to 6 Weeks', 'description': 'The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):\n\n* Mild = VAS 0-3\n* Moderate = VAS \\> 3-7\n* Severe = VAS \\> 7-10', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '17.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks', 'description': 'Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Descriptive About Occurrence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 to 6 Weeks', 'description': 'Safety will be evaluated by the Adverse events occurence', 'unitOfMeasure': 'reported adverse events', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluation of Results of General Physical Examination', 'timeFrame': '4 to 6 Weeks', 'description': 'Collection of safety data throughout the whole study period', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '\\> 18 years old', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'visual analogue scale (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '2.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):\n\nMild = VAS 0-3 Moderate = VAS \\> 3-7 Severe = VAS \\> 7-10', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Nasal Symptom Score (TNSS)', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '3.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nasal Obstruction and Septoplasty Effectiveness (NOSE) score', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '19.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '22-item Sino-Nasal Outcome Test (SNOT-22)', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '20.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'peak nasal inspiratory flow (PNIF)', 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'spread': '43.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'L/min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-12', 'size': 511036, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-07T12:02', 'hasProtocol': True}, {'date': '2019-03-12', 'size': 212094, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-14T12:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2019-03-26', 'resultsFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-21', 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Descriptive About Occurrence of Adverse Events', 'timeFrame': '4 to 6 Weeks', 'description': 'Safety will be evaluated by the Adverse events occurence'}, {'measure': 'Evaluation of Results of General Physical Examination', 'timeFrame': '4 to 6 Weeks', 'description': 'Collection of safety data throughout the whole study period'}], 'primaryOutcomes': [{'measure': 'Change in Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks', 'timeFrame': 'Total Nasal Symptom Score (TNSS) at 4 to 6 Weeks', 'description': 'Change from baseline to week 6 in subject congestion symptom severity, as measured by the Total Nasal Symptom Score (TNSS, range 0-3). Where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 15.'}], 'secondaryOutcomes': [{'measure': 'Change in Peak Nasal Inspiratory Flow Test (PNIF Test)', 'timeFrame': 'Peak Nasal Inspiratory Flow Test (PNIF Test) score at 2 Weeks', 'description': 'Change from baseline to week 2 in subject nasal airway obstruction, as measure by the Peak Nasal Inspiratory Flow Test (PNIF Test). The PNIF is used to diagnose the patency of the nose.'}, {'measure': 'Change in Sinonasal Outcome Test 22 (SNOT-22) Total Score', 'timeFrame': 'Sinonasal Outcome Test 22 (SNOT-22) Total Score at 4 to 6 Weeks', 'description': 'Change from baseline to week 6 in subject symptoms and functioning, as measured by Sinonasal Outcome Test - 22 (SNOT-22). SNOT-22 is a subject-completed questionnaire that consists of 22 questions. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The total score can range from 0-110, 0 being the best and 110 being the worst.'}, {'measure': 'Change in Visual Analog Scale (VAS)', 'timeFrame': 'Visual Analog Scale (VAS) score at 4 to 6 Weeks', 'description': 'The visual analog scale (VAS) for rhinosinusitis is used to evaluate the total severity. The subject is asked to indicate on a VAS the answer to the question: "How troublesome are your symptoms of rhinosinusitis?" Subject will assess Nasal symptoms using a 10 cm Visual Analog Scale for each symptom, 0=not troublesome and 10 = the worst imaginable. The disease can be divided into Mild, Moderate and Severe based on total severity VAS score (0 to 10 cm):\n\n* Mild = VAS 0-3\n* Moderate = VAS \\> 3-7\n* Severe = VAS \\> 7-10'}, {'measure': 'Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale)', 'timeFrame': 'Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale) score at 4 to 6 Weeks', 'description': 'Change from baseline to week 6 in subject nasal congestion severity, as measured by the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE Scale). The NOSE scale is a subject-completed questionnaire that consists of 5 questions. Each item is rated as follows: 0=not a problem, 1=very mild problem, 2=moderate problem, 3=fairly bad problem, 4=severe problem. The total score can range from 0-100, 0 being the best and 100 being the worst.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Nasal Congestion']}, 'referencesModule': {'references': [{'pmid': '32104962', 'type': 'DERIVED', 'citation': 'Soler ZM, Nguyen SA, Salvador C, Lackland T, Desiato VM, Storck K, Schlosser RJ. A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion. Int Forum Allergy Rhinol. 2020 May;10(5):610-618. doi: 10.1002/alr.22537. Epub 2020 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to test the safety and effectiveness of the SinuSonic device on adults with moderate to severe nasal congestion. SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. This device is held over the nose for 3 minutes. This study will use patient responses to measure how effective SinuSonic devices are in treating these moderate to severe congestion in adults. The study will consist of 40 subjects at the Medical University of South Carolina and will take place over the course of 4 to 6 weeks starting with a baseline assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥18 years of age\n2. Complaints of nasal congestion present for 2 weeks or more and a qualifying nasal congestion score of \\>5 (10 point VAS scale)\n\nExclusion Criteria:\n\n1. Fixed structural cause of nasal congestion (moderate or severe septal deviation, moderate or severe nasal valve collapse, Grade 3-4 polyp)\n2. Inability to read and understand English\n3. Allergic sensitivity to silicone or any other component of device\n4. History of severe nose bleeding within last 3 months\n5. Anticoagulation (Aspirin is acceptable)\n6. Known pregnancy\n7. Current nasal crusting or ulceration revealed on rhinoscopy\n8. Inability to perform treatment due to underlying medical condition\n9. Topical decongestant use in last week'}, 'identificationModule': {'nctId': 'NCT03906968', 'briefTitle': 'The Safety and Efficacy of a SinuSonic Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'SinuSonic Study for Adults With Nasal Congestion', 'orgStudyIdInfo': {'id': 'Pro00083883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SinuSonic Device', 'description': 'SinuSonic Device used twice a day for four to six weeks.', 'interventionNames': ['Device: SinuSonic Device']}], 'interventions': [{'name': 'SinuSonic Device', 'type': 'DEVICE', 'description': 'A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion', 'armGroupLabels': ['SinuSonic Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Sinus Center - Medical Univesity of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Zachary M Soler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not Applicable. We plan to publish this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}