Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03541018
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Treatments With the TRV Reposition Chair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065635', 'term': 'Benign Paroxysmal Positional Vertigo'}], 'ancestors': [{'id': 'D014717', 'term': 'Vertigo'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation by VNG Measurements', 'timeFrame': '2 years', 'description': 'Video NystagmoGraphy (VNG) equipment will objectively quantify nystagmus characteristics during diagnostic procedures.'}, {'measure': 'Subjective vertigo', 'timeFrame': '2 years', 'description': 'A systematic registration of experienced vertigo during each diagnostic procedure will take place.'}], 'secondaryOutcomes': [{'measure': 'Dizziness Handicap Inventory (DHI) questionnaire', 'timeFrame': '2 years', 'description': 'Pre-treatment fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TRV Reposition Chair', 'Epley Maneuvre'], 'conditions': ['Benign Paroxysmal Positional Vertigo']}, 'descriptionModule': {'briefSummary': 'To investigate which treatment option (reposition maneuver) with the TRV chair that is the most effective in patients diagnosed with benign paroxysmal positional vertigo (BPPV). Subtypes of BPPV will be examined after randomization to specific treatments.', 'detailedDescription': 'Patients diagnosed with BPPV with subtypes of either posterior canalolithiasis or lateral cupulolithiasis will we considered for enrollment. Each subgroup of patients will undergo randomization for a specific treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years of age\n* Medical history compatible with BPPV\n* Verification of BPPV with either Dix-Hallpike Maneuver or Supine Roll Test.\n\nExclusion Criteria:\n\n* Former treatment with a repositional Chair\n* Not being able to participate or cooperate in the treatment provided by the TRV Repositional Chair'}, 'identificationModule': {'nctId': 'NCT03541018', 'briefTitle': 'Different Treatments With the TRV Reposition Chair', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Which Repositional Maneuver is the Most Successful When Treating Lateral and Posterior Benign Paroxysmal Positional Vertigo With the TRV Repositional Chair?', 'orgStudyIdInfo': {'id': 'VEST01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posterior canalolithiasis', 'description': 'Type of repositional maneuvre', 'interventionNames': ['Procedure: Type of repositional maneuvre']}, {'type': 'EXPERIMENTAL', 'label': 'Lateral cupulolithiasis', 'description': 'Type of repositional maneuvre', 'interventionNames': ['Procedure: Type of repositional maneuvre']}], 'interventions': [{'name': 'Type of repositional maneuvre', 'type': 'PROCEDURE', 'description': 'Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV', 'armGroupLabels': ['Lateral cupulolithiasis', 'Posterior canalolithiasis']}]}, '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, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assistant Professor', 'investigatorFullName': 'Dan Dupont Hougaard', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}