Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 7:58 AM
Study NCT ID:
NCT00000359
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatments for Benign Paroxysmal Positional Vertigo (BPPV)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '1999-11-02', 'lastUpdatePostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertigo', 'timeFrame': '6 month s'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical Therapy', 'Vertigo', 'rehabilitation', 'occupational therapy'], 'conditions': ['Vertigo']}, 'referencesModule': {'references': [{'pmid': '15021771', 'type': 'BACKGROUND', 'citation': 'Cohen HS. Side-lying as an alternative to the Dix-Hallpike test of the posterior canal. Otol Neurotol. 2004 Mar;25(2):130-4. doi: 10.1097/00129492-200403000-00008.'}, {'pmid': '15103195', 'type': 'RESULT', 'citation': 'Cohen HS, Kimball KT, Stewart MG. Benign paroxysmal positional vertigo and comorbid conditions. ORL J Otorhinolaryngol Relat Spec. 2004;66(1):11-5. doi: 10.1159/000077227.'}, {'pmid': '15011204', 'type': 'RESULT', 'citation': 'Cohen HS, Kimball KT. Treatment variations on the Epley maneuver for benign paroxysmal positional vertigo. Am J Otolaryngol. 2004 Jan-Feb;25(1):33-7. doi: 10.1016/j.amjoto.2003.09.010.'}, {'pmid': '16151355', 'type': 'RESULT', 'citation': 'Cohen HS, Kimball KT. Effectiveness of treatments for benign paroxysmal positional vertigo of the posterior canal. Otol Neurotol. 2005 Sep;26(5):1034-40. doi: 10.1097/01.mao.0000185044.31276.59.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the relative short- and long-term efficacy of several physical treatment paradigms commonly employed for the treatment of benign paroxysmal positional vertigo (BPPV), including the canalith repositioning (Epley) maneuver, the liberatory (Semont) maneuver, the Brandt-Daroff exercises and nonspecific vestibular habituation exercises. These procedures involve exercises and head manipulations. Vertigo intensity and frequency, the presence/absence of slow-phase eye movements, the degree of dizziness handicap and acts of daily living (ADL) were assessed. The study also ascertained the effects of co-morbid conditions on the response to treatment. While BPPV is a common and significant public health problem that has been recognized for several decades, this is the first systematic study of the relative treatment efficacy of different physical treatment modalities for this disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients may be eligible for this study if they:\n\n* Are at least 21 years old.\n* Have a diagnosis of unilateral posterior semicircular canal BPPV according to established clinical test criteria.\n* Have functional to normal range of motion of the neck and the back.\n\nExclusion Criteria:\n\nPatients will not be eligible for this study if they:\n\n* Have a history of prior ear surgery or prior treatment for BPPV.\n* Have an orthopedic or connective tissue disorder that impairs functional neck or trunk range of motion.\n* Have a significant neurological disorder or spinal cord damage.\n* Are on vestibular suppressant medications.\n* Have Meniere's disease or acoustic neuromas."}, 'identificationModule': {'nctId': 'NCT00000359', 'briefTitle': 'Treatments for Benign Paroxysmal Positional Vertigo (BPPV)', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Treatments for Benign Paroxysmal Positional Vertigo (BPPV)', 'orgStudyIdInfo': {'id': 'NIDCD-1156'}, 'secondaryIdInfos': [{'id': 'R01DC003602', 'link': 'https://reporter.nih.gov/quickSearch/R01DC003602', 'type': 'NIH'}, {'id': '1R01DC003602-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DC003602-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canalith repositioning maneuver', 'description': 'Repositioning treatment for posterior canal BPPV', 'interventionNames': ['Behavioral: Canalith repositioning maneuver (Epley maneuver)']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Epley maneuver', 'interventionNames': ['Behavioral: Vestibular habituation exercises']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'The subject sat in a chair; the head was passively tilted downward, turned away from the involved side, turned back to center, upward, away from the involved side, twice, slowly.', 'interventionNames': ['Behavioral: ShamManeuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liberatory maneuver', 'description': 'The standard liberatory maneuver (also known as the Semont maneuver) was used.', 'interventionNames': ['Behavioral: Semont maneuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brandt Daroff exercise', 'description': 'Modified Brandt Daroff exercise performed as a self-liberatory exercise.', 'interventionNames': ['Behavioral: Brandt-Daroff exercises']}], 'interventions': [{'name': 'Canalith repositioning maneuver (Epley maneuver)', 'type': 'BEHAVIORAL', 'otherNames': ['CRP', 'Epley maneuver'], 'description': 'Standard passive motion of the head: Dix-Hallpike maneuver, turn head to opposite side, roll over, sit up.', 'armGroupLabels': ['Canalith repositioning maneuver']}, {'name': 'Semont maneuver', 'type': 'BEHAVIORAL', 'otherNames': ['Liberatory maneuver'], 'description': 'Sidelying maneuver, flip over 180 deg, sit up.', 'armGroupLabels': ['Liberatory maneuver']}, {'name': 'Brandt-Daroff exercises', 'type': 'BEHAVIORAL', 'description': 'Active exercise. Sidelying to involved side, sidelying to uninvolved side, sit up.', 'armGroupLabels': ['Brandt Daroff exercise']}, {'name': 'Vestibular habituation exercises', 'type': 'BEHAVIORAL', 'description': 'Head shaking exercises in pitch, roll, yaw and circumduction. Titrating from 2 repetitions per exercise to 20 repetitions per exercise, as tolerated.', 'armGroupLabels': ['Modified Epley maneuver']}, {'name': 'ShamManeuver', 'type': 'BEHAVIORAL', 'description': 'Passive movement of the head', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Helen Cohen, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Helen Cohen', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}