Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05479604
Status:
TERMINATED
Last Update Posted:
2025-09-10
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005157', 'term': 'Facial Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'miglani.amar@mayo.edu', 'phone': '4803422929', 'title': 'Amar Miglani, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Other specified disorders of nose and nasal sinuses', 'notes': 'J34.89 - Other specified disorders of nose and nasal sinuses. Notes: patient reported nose scabbing when using the real device (not sham).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Facial Pain Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Facial Pain - Visual Analogue Scale (VAS)'}, {'type': 'PRIMARY', 'title': 'Change in Brief Pain Inventory Short Form (BPI-SF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects Reporting Pain With Device Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Number of subjects reporting pain with device use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjects Reporting Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Number of subjects reporting epistaxis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Nasal Obstruction Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'OG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}], 'classes': [{'categories': [{'measurements': [{'value': '61.1', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '21.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': "The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'FG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '9 Participants', 'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'The study consisted of both pre-screening and screening measures, where screening measures took place after consent. Two participants were assigned study numbers at the time of consent and screen failed based on screening criteria. Another two participants who were assigned study numbers refused further participation following the consent visit, who met screening criteria, prior to being randomized. One participant met screening criteria, but the study was stopped prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks\n\nSinuSonic: Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.'}, {'id': 'BG001', 'title': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks\n\nSham Device: Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '54', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '53', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', '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': '0', 'groupId': 'BG001'}, {'value': '0', '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': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Visual Analogue Scale (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Visual Analogue Scale (VAS) for Facial Pain is a validated, self-reported tool used to assess the severity of facial pain. Participants are asked to rate their current facial pain intensity on a scale from 0 to 10, with 0 indicating "no pain" and 10 representing the "worst pain imaginable." Higher scores reflect worse outcomes, meaning more severe facial pain, while lower scores indicate better outcomes, or less pain. The score is reported directly by the participant based on their subjective experience. This is a single-item measure, and no subscales or composite scores are used.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': "Only complete datasets that contained all primary and secondary outcome measures at 'Baseline' and 'Week 8' timepoints were analyzed in the final data analysis process."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-09', 'size': 648419, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-14T15:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'participant non-compliance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2022-07-27', 'resultsFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-20', 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Facial Pain Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Participants rated sinus or facial pain/pressure using a 0-10 Visual Analogue Scale (VAS) which measured the average sinus pain over the past week. The VAS was displayed as a horizontal sliding scale on an electronic survey, where participants moved a slider along a continuum from 0 = no pain to 10 = worst possible pain. The slider allowed for selection of whole-number values only. Higher scores indicate worse outcomes (greater pain); lower scores indicate better outcomes (less pain).'}, {'measure': 'Change in Brief Pain Inventory Short Form (BPI-SF)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The Brief Pain Inventory - Short Form (BPI-SF) is a 9-item self-report questionnaire that assesses pain severity and its impact on daily functioning. Pain intensity (worst, least, average, current) and pain interference (e.g., activity, mood, sleep) are rated on a 0-10 scale, with 0 = no pain/no interference and 10 = worst pain/completely interferes. Higher scores indicate worse outcomes, whereas lower scores indicate better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Subjects Reporting Pain With Device Use', 'timeFrame': '8 weeks', 'description': 'Number of subjects reporting pain with device use'}, {'measure': 'Subjects Reporting Epistaxis', 'timeFrame': '8 weeks', 'description': 'Number of subjects reporting epistaxis'}, {'measure': 'Change in Nasal Obstruction Symptoms', 'timeFrame': 'Baseline, 8 weeks', 'description': "The Nasal Obstruction Symptom Evaluation (NOSE) Score is a 5-item, self-reported survey that assesses the impact of nasal obstruction on quality of life over the past month; each item is rated from 0 (not a problem) to 4 (severe problem). These five items form a single subscale (i.e., nasal obstruction symptom severity). The responses to all 5 items are summed to yield a raw total score ranging from 0 to 20. Raw scores are scaled to a total score out of 100, by multiplying by 5. Nasal Obstruction Severity Classification categories: Mild (5-25), Moderate (30-50), Severe (55-75), Extreme (80-100). A score of 0 means that there are no problems with nasal obstruction and a score of 100 means that they are experiencing the worst possible problems with nasal obstruction. NOSE scores will be obtained at 'Baseline' and 'Week 8,' to measure obstruction changes with device use (sham vs real)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Facial Pressure'], 'conditions': ['Facial Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be \\> 18 years of age inclusive, at the time of signing the informed consent.\n* Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Facial pain or pressure for \\> 3 months of symptom duration.\n* Pain/pressure VAS (Visual Analogue Scale) Score of \\> 5.\n\nExclusion Criteria:\n\n* Upper respiratory illness within the last 2 weeks.\n* History of severe epistaxis.\n* Known pregnancy.\n* Allergic sensitivity to silicone or any other component of device.\n* Sinonasal surgery in the last 3 months.\n* Topical decongestant use in the last week.\n* Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.\n* Sinusitis on imaging.\n* Nasal crusting or ulceration on exam.\n* Inability to read or understand English.'}, 'identificationModule': {'nctId': 'NCT05479604', 'briefTitle': 'Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '22-001904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SinuSonic Group', 'description': 'Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks', 'interventionNames': ['Device: SinuSonic']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'Subjects will use the sham device for 2 minutes twice daily for 8 weeks', 'interventionNames': ['Device: Sham Device']}], 'interventions': [{'name': 'SinuSonic', 'type': 'DEVICE', 'description': 'Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.', 'armGroupLabels': ['SinuSonic Group']}, {'name': 'Sham Device', 'type': 'DEVICE', 'description': 'Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device', 'armGroupLabels': ['Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Amar Miglani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amar Miglani', 'investigatorAffiliation': 'Mayo Clinic'}}}}