Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT03973658
Status:
UNKNOWN
Last Update Posted:
2019-07-30
First Post:
2019-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dizziness Among First Time Users of Hearing Aids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2019-06-02', 'studyFirstSubmitQcDate': '2019-06-02', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dizziness Handicap Inventory (short version) score. The scale measures the degree of dizziness associated handicap as experienced by the patient. Minimun score: 0 Maximum score: 13. A higher score means better outcome.', 'timeFrame': '2 months', 'description': 'The change in the score a 2 months after fitting the hearing aids'}], 'secondaryOutcomes': [{'measure': 'Usage of hearing aids', 'timeFrame': '2 months', 'description': 'The duration the participants used the hearing aids'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dizziness', 'Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The score on the Dizziness Handicap Inventory (short version) before and after hearing aid fitting and usage will be compared'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18 years and older patients using hearing aids for the first time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hebrew speaking\n* First time users of hearing aids\n\nExclusion Criteria:\n\n* Using a wheelchair\n* Neurological disorders\n* Spine of leg surgery in the previous 6 months'}, 'identificationModule': {'nctId': 'NCT03973658', 'briefTitle': 'Dizziness Among First Time Users of Hearing Aids', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Dizziness Among First Time Users of Hearing Aids', 'orgStudyIdInfo': {'id': '0132-18-COM2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First time users of hearing aids', 'description': 'Hearing aid fitting and usage', 'interventionNames': ['Device: Hearing aids']}], 'interventions': [{'name': 'Hearing aids', 'type': 'DEVICE', 'description': 'Fitting of hearing aids (for the first time)', 'armGroupLabels': ['First time users of hearing aids']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yahav Oron, MD', 'role': 'CONTACT', 'email': 'orony@clalit.org.il', 'phone': '972-3-5772450'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}