Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 10:39 PM
Study NCT ID:
NCT04468204
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2020-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nguyensh@musc.edu', 'phone': '(843)792-1356', 'title': 'Director of Clinical Research', 'organization': 'Department of Otolaryngology - Head and Neck Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 1, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Sham SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Symptoms Score (TSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.503', 'spread': '0.501', 'groupId': 'OG000'}, {'value': '0.843', 'spread': '0.569', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 Days', 'description': 'The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.\n\nThe TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.\n\nThe severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms)\n\nMinimum score=0; maximum score=27.', 'unitOfMeasure': 'scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.'}, {'id': 'FG001', 'title': 'Sham', 'description': 'Sham SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SinuSonic Device', 'description': 'SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSinuSonic Device: A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.'}, {'id': 'BG001', 'title': 'Sham', 'description': 'Sham SinuSonic device used for 1 min three times a day for 8 weeks.\n\nSham SinuSonic Device: Sham positive expiratory pressure intervention using the SinuSonic Device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '69'}, {'value': '48.5', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '69'}, {'value': '46.8', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-20', 'size': 364801, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-23T15:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2020-07-08', 'resultsFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-22', 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Symptoms Score (TSS)', 'timeFrame': '60 Days', 'description': 'The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom.\n\nThe TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness.\n\nThe severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms)\n\nMinimum score=0; maximum score=27.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Upper Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.\n\nExclusion Criteria:\n\n* Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.\n* Any upper respiratory illness within last 2 weeks\n* TSS will be measured at baseline as described above and must be \\<9 for inclusion (Eccles etal).\n* Topical decongestant use in last week\n* Current nasal crusting or history of ulceration or perforation\n* History of severe nose bleeding within last 3 months\n* Known pregnancy\n* Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy\n* Allergic sensitivity to silicone or any other component of device\n* Inability to read and understand English\n* Inability to perform treatment due to underlying medical condition'}, 'identificationModule': {'nctId': 'NCT04468204', 'briefTitle': 'Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)', 'orgStudyIdInfo': {'id': 'Pro00100980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SinuSonic Device', 'description': 'SinuSonic device used for 1 min three times a day for 8 weeks.', 'interventionNames': ['Device: SinuSonic Device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Sham SinuSonic device used for 1 min three times a day for 8 weeks.', 'interventionNames': ['Device: Sham 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']}, {'name': 'Sham SinuSonic Device', 'type': 'DEVICE', 'otherNames': ['Sham'], 'description': 'Sham positive expiratory pressure intervention using the SinuSonic Device.', 'armGroupLabels': ['Sham']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not Applicable. The investigators plan to publish this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shaun A. Nguyen, MD', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}