Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04147156
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV
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': 'D004244', 'term': 'Dizziness'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}], 'ancestors': [{'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': 'D012678', 'term': 'Sensation Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatments', 'timeFrame': '2 years', 'description': 'Number of treatments necessary to achieve resolution of vertigo and nystagmus'}, {'measure': 'Treatment success after first treatment', 'timeFrame': '2 years', 'description': 'Number of subjects achieving resolution of vertigo and nystagmus after one treatment'}], 'secondaryOutcomes': [{'measure': 'Dizziness Handicap Inventory (DHI) questionnaire', 'timeFrame': '2 years', 'description': 'Comparison of pre- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition'}, {'measure': 'Adverse events', 'timeFrame': '2 years', 'description': 'Registration of adverse events'}, {'measure': 'Value of liberatory nystagmus', 'timeFrame': '2 years', 'description': 'Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benign Paroxysmal Positional Vertigo', 'Vertigo', 'Dizziness', 'Vestibular diseases', 'Epley Maneuver', 'Semont Maneuver', 'Repositioning chair'], 'conditions': ['BPPV']}, 'descriptionModule': {'briefSummary': 'A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.', 'detailedDescription': "Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair:\n\n1. Epley's maneuver\n2. Semont maneuver\n3. 360 degree vertical rotation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Characteristic (for BPPV) positional nystagmus\n* Positive Dix-Hallpike Test\n* Medical history compatible with BPPV\n\nExclusion Criteria:\n\n* Treatment in a mechanical rotational chair within the last 6 months\n* Exclusion of BPPV diagnosis\n* Lack of treatment cooperation\n* Known cerebral aneurism or cerebral hemorrhage\n* Treated for BPPV within the past month'}, 'identificationModule': {'nctId': 'NCT04147156', 'briefTitle': 'Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) in Treating BPPV', 'orgStudyIdInfo': {'id': 'ROTDUNDUM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Epley's Maneuver", 'description': "Treatment of posterior canal BPPV with Epley's maneuver in the ROTUNDUM-chair.", 'interventionNames': ["Procedure: Epley's Maneuver"]}, {'type': 'EXPERIMENTAL', 'label': 'Semont Maneuver', 'description': 'Treatment of posterior canal BPPV with the Semont maneuver in the ROTUNDUM-chair.', 'interventionNames': ['Procedure: Semont Maneuver']}, {'type': 'ACTIVE_COMPARATOR', 'label': '360 degree vertical rotation', 'description': 'Treatment of posterior canal BPPV with a 360 degree vertical rotation in the ROTUNDUM-chair.', 'interventionNames': ['Procedure: 360 degree vertical rotation']}], 'interventions': [{'name': "Epley's Maneuver", 'type': 'PROCEDURE', 'description': "Treatment with Epley's Maneuver in the ROTUNDUM-chair", 'armGroupLabels': ["Epley's Maneuver"]}, {'name': 'Semont Maneuver', 'type': 'PROCEDURE', 'description': 'Treatment with the Semont Maneuver in the ROTUNDUM-chair', 'armGroupLabels': ['Semont Maneuver']}, {'name': '360 degree vertical rotation', 'type': 'PROCEDURE', 'description': 'Treatment with 360 degree vertical rotation in the ROTUNDUM-chair', 'armGroupLabels': ['360 degree vertical rotation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'Department of Otolaryngology, Head & Neck Surgery and Audiology', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Dan D Hougaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor, Principal Investigator', 'investigatorFullName': 'Dan Dupont Hougaard', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}