Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-01 @ 5:39 PM
Study NCT ID:
NCT01822002
Status:
UNKNOWN
Last Update Posted:
2013-04-01
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065635', 'term': 'Benign Paroxysmal Positional Vertigo'}, {'id': 'D014717', 'term': 'Vertigo'}, {'id': 'D009759', 'term': 'Nystagmus, Pathologic'}], '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': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-29', 'studyFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of repositioning maneuvers for treating PC-BPPV', 'timeFrame': '2hr', 'description': 'The immediate treatment response will be determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus will be required to determine a resolution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vertigo', 'Nystagmus', 'BPPV = benign paroxysmal positional vertigo', 'Treatment outcome'], 'conditions': ['Benign Paroxysmal Positional Vertigo (BPPV)']}, 'referencesModule': {'references': [{'pmid': '28755307', 'type': 'DERIVED', 'citation': 'Oh SY, Kim JS, Choi KD, Park JY, Jeong SH, Lee SH, Lee HS, Yang TH, Kim HJ. Switch to Semont maneuver is no better than repetition of Epley maneuver in treating refractory BPPV. J Neurol. 2017 Sep;264(9):1892-1898. doi: 10.1007/s00415-017-8580-2. Epub 2017 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'To determine the immediate therapeutic efficacies of canalith repositioning maneuvers in each type of BPPV (posterior canal type, apogeotropic horizontal canal type and geotropic horizontal canal type).', 'detailedDescription': 'In nationwide 10 Dizziness Clinics of Korea, consecutive patients with each type of BPPV are randomized to each repositioning maneuver.\n\nFor posterior canal type of BPPV (PC-BPPV), patinets are randomized into modified Epley maneuver and Semont maneuver.\n\nSubjects Consecutive patients with a diagnosis of PC-BPPV are recruited from nationwide 10 Dizziness Clinics in Korea. The inclusion criteria for this study were (1) a history of positional vertigo, (2) direction-changing positional nystagmus appropriate for each type of BPPV, and (3) absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus. To exclude the patients with nystagmus from central pathologies, all patients also will receive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations. Even in patients with isolated vertigo, those with central ocular motor signs, limb ataxia, and severe imbalance will be arranged for MRIs.\n\nDiagnostic procedure To induce positional nystagmus, the patients lied supine from sitting (lying-down nystagmus) and turned their heads to either side while in supine (head-turning nystagmus). Then the patients were moved from a supine to sitting position and the head was bent down (head-bending nystagmus). Patients were also subjected to right and left Hallpike maneuvers and straight head hanging test to exclude BPPV involving the posterior or anterior canal.\n\nStudy design and Randomization The investigators attempt to determine the immediate therapeutic efficacies of Epley maneuver and Semont maneuver for PC-BPPV, repeated barbecue rotation maneuver and Gufoni maneuver after barbecue rotatio maneuver for geotropic HC-BPPV, and repeated Gufoni maneuver and head-shaking maneuvers after Gufoni maneuver in apogeotropic HC-BPPV by adopting a prospective randomized controlled study design.\n\nBased on the data from the pilot study, the investigators estimated the proportion of immediate resolution would be 60-70% in the repositioning groups. By adopting 0.9 power to detect a significant difference (p=0.05, two-sided) and a drop rate of 5%, 200 patients of each type of BPPV will be required for each treatment arm.\n\nThe immediate treatment response will be determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus will be required to determine a resolution. When the patient still show positioning nystagmus or vertigo, the patient will be received the another maneuver at each protocol arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a history of positional vertigo\n2. upbeating-torsional nystagmus in Dix-Hallpike maneuver\n3. absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.\n\nExclusion Criteria:\n\n(1) Patients with positive neurotological examinations including spontaneous and gaze-evoked (GEN) nystagmus, horizontal and vertical smooth pursuit and saccades, limb ataxia, and balance function in addition to routine neurological examinations.'}, 'identificationModule': {'nctId': 'NCT01822002', 'acronym': 'PC-BPPV', 'briefTitle': 'Treatment of Posterior Canal Type of Benign Paroxysmal Positional Vertigo', 'organization': {'class': 'OTHER', 'fullName': 'Chonbuk National University'}, 'officialTitle': 'Randomized Controlled Trials for Treatment of Benign Paroxysmal Positional Vertigo', 'orgStudyIdInfo': {'id': 'Treatment of PC-BPPV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Canalith repositionig maneuver; Epley maneuver group', 'description': 'Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver.', 'interventionNames': ['Procedure: Canalith repositioning maneuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Canalith repositioning maneuver : Semont maneuver group', 'description': 'Patients with PC-BPPV will be randomly assigned to Epley maneuver or Semont maneuver group.', 'interventionNames': ['Procedure: Canalith repositioning maneuver']}], 'interventions': [{'name': 'Canalith repositioning maneuver', 'type': 'PROCEDURE', 'otherNames': ['Epley maneuver', 'Semont maneuver'], 'armGroupLabels': ['Canalith repositionig maneuver; Epley maneuver group', 'Canalith repositioning maneuver : Semont maneuver group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '561 781', 'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sun-Young Oh, MD', 'role': 'CONTACT', 'email': 'ohsun@jbnu.ac.kr', 'phone': '82 10 5538 6565'}, {'name': 'Hyu-Jeong Kim', 'role': 'CONTACT', 'email': 'sasakp@naver.com'}], 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}], 'centralContacts': [{'name': 'Sun-Young Oh, MD', 'role': 'CONTACT', 'email': 'ohsun@jbnu.ac.kr', 'phone': '82 10 5538 6565'}, {'name': 'Hyo-Jeong Kim', 'role': 'CONTACT', 'email': 'sasakp@naver.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonbuk National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sun-Young Oh', 'investigatorAffiliation': 'Chonbuk National University'}}}}