Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-31 @ 8:49 PM
Study NCT ID:
NCT03431506
Status:
UNKNOWN
Last Update Posted:
2018-02-13
First Post:
2018-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-11', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-02-11', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)', 'timeFrame': 'before treatment', 'description': 'Vestibular function status in SSHL with vertigo at stage 1(before treatment)'}], 'secondaryOutcomes': [{'measure': 'Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)', 'timeFrame': '2 weeks after treatment', 'description': 'Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment)'}, {'measure': 'Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)', 'timeFrame': '2 months after treatment', 'description': 'Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vestibular Disorder']}, 'descriptionModule': {'briefSummary': 'To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo', 'detailedDescription': 'Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;\n2. Within 10 days from onset;\n3. Without other virus infectious disease within three months.\n\nExclusion Criteria:\n\n1. BPPV; Meniere's disease and vestibular migraine.\n2. With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc"}, 'identificationModule': {'nctId': 'NCT03431506', 'briefTitle': 'Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo', 'orgStudyIdInfo': {'id': 'Vestibular function in SSHL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non-training group', 'interventionNames': ['Behavioral: Vestibular rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'training group', 'interventionNames': ['Behavioral: Vestibular rehabilitation']}], 'interventions': [{'name': 'Vestibular rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Vestibular Rehabilitation Exercises', 'armGroupLabels': ['non-training group', 'training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huawei Li, Phd &MD', 'role': 'CONTACT', 'email': 'huaweili2000@shmu.edu.cn'}, {'name': 'Huawei Li, Phd &MD', 'role': 'CONTACT', 'email': 'huaweili2000@163.com'}], 'facility': 'Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huawei Li, Phd &MD', 'role': 'CONTACT', 'email': 'huaweili2000@163.com', 'phone': '+86-13636423139'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}