Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT02503592
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vestibular function in Cochlear Implant Patients', 'timeFrame': 'Pre-Operatively, and then 3 months and 12 months post-operatively', 'description': 'Vestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery'}, {'measure': 'Change in Quality of Life by questionnaire', 'timeFrame': '3 months and 12 months post-operatively', 'description': 'Self-reported quality of life questionnaire (DHI) will be collected 3 months and 12 months post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vestibular Function in Cochlear Implant Patients']}, 'descriptionModule': {'briefSummary': 'This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery. Additionally, the investigators will attempt to systematically evaluate the utility of different electrophysiological measures of vestibular system function in surgical ears.\n\nVestibular system function in CI patients will be evaluated pre-surgically and twice post-surgically, at 3 months and again at 1 year post-surgery. Traditional test techniques - such as VNG, rotational testing, and air conduction VEMPs - will be compared to and cross-checked with newer techniques including video head impulse testing (vHIT) and bone conduction VEMPs.', 'detailedDescription': "Design \\& Procedures: The current standard of care for CI patients includes a pre-op evaluation of the vestibular system. For this study, the investigators will compare subjects' routine pre-op test results to two additional post-op assessments performed for study purposes: one in the short term (\\~3 months post-op) and one in the long-term (\\~1 year post-op)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n* Only patients implanted with the MED-EL CI device within the last 90 days will be eligible for this study.\n\nExclusion Criteria:\n\n* Patients \\< 18 years of age\n* Patients implanted with a cochlear implant device other than MED-El CI'}, 'identificationModule': {'nctId': 'NCT02503592', 'briefTitle': 'Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques', 'orgStudyIdInfo': {'id': 'Pro00060216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cochlear Implant group - Vestibular testing', 'description': 'Adult patients who have been implanted with a Med-El Cochlear implant device within the last 3 months who completed pre-op vestibular testing as standard of care. These subjects will undergo a series of post-op vestibular testing, at the 3 month and 12 month follow up visits', 'interventionNames': ['Other: Vestibular testing']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group - existing historical vestibular data', 'description': 'This group will consist of existing historical vestibular testing data only. No subjects will be enrolled on this arm.'}], 'interventions': [{'name': 'Vestibular testing', 'type': 'OTHER', 'description': 'Patients who have received a cochlear implant within 90 days, and had vestibular testing pre-operatively, will undergo post-op vestibular testing', 'armGroupLabels': ['Cochlear Implant group - Vestibular testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Erin Piker, AuD, PhD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}