Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-31 @ 2:43 AM
Study NCT ID:
NCT04396132
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2020-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}], 'ancestors': [{'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-11', 'studyFirstSubmitDate': '2020-05-17', 'studyFirstSubmitQcDate': '2020-05-17', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Visual Vertical', 'timeFrame': '1 month', 'description': 'The measurement of deviation angle with 15, 30 and 45-degree head tilt to the left and right side while they are standing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vestibular Nerve Diseases']}, 'descriptionModule': {'briefSummary': 'The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.', 'detailedDescription': 'Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No ear disease\n* No neurologic disease\n* No surgery for ear, brain or musculoskeletal system\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Drug use effective on central nervous system'}, 'identificationModule': {'nctId': 'NCT04396132', 'briefTitle': 'The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual SVV', 'description': 'The subjects will be tested by virtual SVV. The deviation angle will be measured at 15, 30 and 45-degree head tilt to the left and right side while they are standing', 'interventionNames': ['Diagnostic Test: Subjective Visual Vertical with Virtual SVV instrument']}], 'interventions': [{'name': 'Subjective Visual Vertical with Virtual SVV instrument', 'type': 'DIAGNOSTIC_TEST', 'description': 'The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing', 'armGroupLabels': ['Virtual SVV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20070', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Fazıl N Ardıç, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department Of Otolaryngology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be shared from university depository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department', 'investigatorFullName': 'Fazıl Necdet Ardıç', 'investigatorAffiliation': 'Pamukkale University'}}}}