Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 5:14 PM
Study NCT ID:
NCT05141734
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2021-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Tests for Patients With Benign Paroxysmal Positional Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012027', 'term': 'Reflex, Vestibulo-Ocular'}], 'ancestors': [{'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D012018', 'term': 'Reflex'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of nystagmus intensity and vestibulo-ocular reflex gains in patients with benign paroxysmal positional vertigo', 'timeFrame': '2019-2010 (15 months)', 'description': 'The vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV) of nystagmus were compared in patients with benign paroxysmal positional vertigo.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vestibular function tests', 'Head Impulse Test', 'semicircular canals'], 'conditions': ['Positional Vertigo', 'Reflexes, Vestibo-Ocular', 'Nystagmus Vestibular']}, 'referencesModule': {'references': [{'pmid': '36776086', 'type': 'DERIVED', 'citation': 'Onal M, Aygun A, Colpan B, Karakayaoglu H, Onal O. Correlation between nystagmus intensity and vestibular-ocular reflex gain in benign paroxysmal positional vertigo: A prospective, clinical study. J Vestib Res. 2023;33(2):115-125. doi: 10.3233/VES-220106.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo.', 'detailedDescription': 'The aim of this study is to investigate the relationship between the vestibulo-ocular reflex (VOR) gains obtained by video Head Impulse Test (vHIT) and the slow phase velocity (SPV) of nystagmus in patients with benign paroxysmal positional vertigo (BPPV) originating from the posterior semicircular canal (PSCC).\n\nThe patients were included in two groups. The study group consisted of patients with isolated PSCC BPPV (PSCC-BPPV), and the control group consisted of age and gender-matched healthy individuals. VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included in the study group were diagnosed with isolated benign paroxysmal positional vertigo (BPPV) according to clinical symptoms.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with isolated benign paroxysmal positional vertigo were included in the study group.\n* The patients included in the control group were composed of those who did not complain of vertigo.\n\nExclusion Criteria:\n\n-Participants with a history of neuro-otologic disease, an orthopedic disease that prevents neck movements, and any disease or surgery that causes impairment in ocular movements were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05141734', 'briefTitle': 'Correlation Tests for Patients With Benign Paroxysmal Positional Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Evaluation of Patients With Benign Paroxysmal Positional Vertigo With vHIT (Video Head Impulse Test) and VNG (Videonystagmography)', 'orgStudyIdInfo': {'id': '2019/54'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BPPV (benign paroxysmal positional vertigo)', 'description': 'VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.', 'interventionNames': ['Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)']}, {'label': 'Control', 'description': 'VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.', 'interventionNames': ['Diagnostic Test: The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)']}], 'interventions': [{'name': 'The relationship between the vestibulo-ocular reflex (VOR) gains and the slow phase velocity (SPV)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The vestibulo-ocular reflex (VOR) gains were measured by video Head Impulse Test (vHIT) in both the study group and the control group. The slow phase velocity (SPV) values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.', 'armGroupLabels': ['BPPV (benign paroxysmal positional vertigo)', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Merih Onal', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Merih Onal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Selcuk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Selcuk University Faculty of Medicine', 'investigatorFullName': 'Merih Onal', 'investigatorAffiliation': 'Selcuk University'}}}}