Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 2:11 PM
Study NCT ID:
NCT04447066
Status:
UNKNOWN
Last Update Posted:
2020-06-25
First Post:
2020-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Semicircular Canal Dysfunction Among Rehabilitation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D004244', 'term': 'Dizziness'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Video Head Impulse Test (vHIT) results', 'timeFrame': '1 year', 'description': 'The results of the vHIT study in terms of gain and saccades'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Vertigo', 'Dizziness']}, 'descriptionModule': {'briefSummary': 'Patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT) study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized at the rehabilitation department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 65 years old\n* Hospitalized at the rehabilitation department\n\nExclusion Criteria:\n\n* Blindness or loss of vision which is not corrected using glasses\n* Past CVA with neurological remnants\n* Movement disorder\n* Lower body part weakness\n* Limitation in neck movement\n* Vestibular pathology diagnosed in the past 6 months'}, 'identificationModule': {'nctId': 'NCT04447066', 'briefTitle': 'The Prevalence of Semicircular Canal Dysfunction Among Rehabilitation Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Semicircular Canals Dysfunction Among Patients Hospitalized at the Rehabilitation Department', 'orgStudyIdInfo': {'id': '255-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients hospitalized at the rehabilitation department', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention - VHIT will be used but without intervention', 'armGroupLabels': ['Patients hospitalized at the rehabilitation department']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yahav Oron, MD', 'role': 'CONTACT', 'email': 'oron.yahav@gmail.com', 'phone': '+972-6973573'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}