Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-04-08 @ 11:00 AM
Study NCT ID:
NCT02701218
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BPPV With CRP: Single Versus Multiple Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-08-20', 'releaseDate': '2021-07-27'}, {'resetDate': '2023-05-11', 'releaseDate': '2022-07-13'}, {'resetDate': '2024-03-19', 'releaseDate': '2023-08-29'}], 'estimatedResultsFirstSubmitDate': '2021-07-27'}}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dix-Hallpike test (DHT)', 'timeFrame': 'At 7th day', 'description': 'percentage of negative DHT between single and multiple cycles'}], 'secondaryOutcomes': [{'measure': 'Dizziness handicap inventory (DHI)', 'timeFrame': 'compare to the first visit at 7th between single and multiple cycles', 'description': 'total score in the questionaire'}, {'measure': 'Dizziness handicap inventory (DHI)', 'timeFrame': 'compare to the first visit at 28th day between single and multiple cycles', 'description': 'total score in the questionaire'}, {'measure': 'Subjective symptoms', 'timeFrame': 'Improvement of the symptoms compare to the first visit at 7th day between single and multiple cycles', 'description': "Asking the patient's symptom: Improve, same, worse"}, {'measure': 'Subjective symptoms', 'timeFrame': 'Improvement of the symptoms compare to the first visit at 28th day between single and multiple cycles', 'description': "Asking the patient's symptom: Improve, same, worse"}, {'measure': 'Loss of balance', 'timeFrame': 'compare to the first visit at 7th between single and multiple cycles', 'description': '5 levels Level 1: Able to continue daily activities without any helps. Level 2: Able to continue daily activities without any helps except complicated activities such as riding a bicycle, walking on counterpoise or scaffolding.\n\nLevel 3: Not able to continue daily activities without help excepts simple activities such as self-care, housework, walking, or being a passenger in a vehicle Level 4: Not able to continue daily activities alone without help except self-care Level 5 Not able to continue daily activities alone without help except self-care without ambulation. Need to stay only in a house or a living place.\n\n(From: The Royal college of Otolaryngologists head and neck surgeons of Thailand, and social security office of thailand)'}, {'measure': 'Loss of balance', 'timeFrame': 'compare to the first visit at 28th day between single and multiple cycles', 'description': '5 levels Level 1: Able to continue daily activities without any helps. Level 2: Able to continue daily activities without any helps except complicated activities such as riding a bicycle, walking on counterpoise or scaffolding.\n\nLevel 3: Not able to continue daily activities without help excepts simple activities such as self-care, housework, walking, or being a passenger in a vehicle Level 4: Not able to continue daily activities alone without help except self-care Level 5 Not able to continue daily activities alone without help except self-care without ambulation. Need to stay only in a house or a living place.\n\n(From: The Royal college of Otolaryngologists head and neck surgeons of Thailand, and social security office of thailand)'}, {'measure': 'Dix-Hallpike test (DHT)', 'timeFrame': 'At 28th day', 'description': 'percentage of negative DHT between single and multiple cycles'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Canalith repositioning procedure (CRP)', 'BPPV'], 'conditions': ['Benign Paroxysmal Positional Vertigo (BPPV)']}, 'referencesModule': {'availIpds': [{'id': 'ENT-2558-03601', 'url': 'http://ros.med.cmu.ac.th/Security/SignIn.aspx', 'type': 'Study Protocol', 'comment': 'Research administration section website'}], 'references': [{'pmid': '18973840', 'type': 'RESULT', 'citation': 'Bhattacharyya N, Baugh RF, Orvidas L, Barrs D, Bronston LJ, Cass S, Chalian AA, Desmond AL, Earll JM, Fife TD, Fuller DC, Judge JO, Mann NR, Rosenfeld RM, Schuring LT, Steiner RW, Whitney SL, Haidari J; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 2008 Nov;139(5 Suppl 4):S47-81. doi: 10.1016/j.otohns.2008.08.022.'}, {'pmid': '32947492', 'type': 'DERIVED', 'citation': 'Isaradisaikul SK, Chowsilpa S, Hanprasertpong C, Rithirangsriroj T. Single Cycle Versus Multiple Cycles of Canalith Repositioning Procedure for Treatment of Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial. Otol Neurotol. 2021 Jan;42(1):121-128. doi: 10.1097/MAO.0000000000002894.'}]}, 'descriptionModule': {'briefSummary': 'Unilateral posterior canal benign paroxysmal positional vertigo (BPPV) cases will be randomized to treat with single or multiple cycles of canalith repositioning procedure.The treatment outcomes will be assessed at 7th and 28th days.', 'detailedDescription': 'Patients present with brief episodes of vertigo will be evaluated by Dix-Hallpike test. Cases with positive Dix-Hallpike test, unilateral, posterior canal, will be randomized with block of four. Either single or multiple cycles of canalith repositioning procedure will be performed. Four treatment outcomes will be blindly assessed at 7 and 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Recurrent episodes of vertigo\n2. 15 years of age or older\n3. Positive Dix-Hallpike test: unilateral, posterior canal\n\nExclusion Criteria:\n\n1. Received vestibular suppressant within 6 hours\n2. With other diseases or conditions cause of vertigo or central nervous system disease\n3. With diseases or conditions contraindicate for Dix-Hallpike test or CRP eg: cervical spine disease, back/ neck stiffness, retinal detachment\n4. Positive Dix-Hallpike test: bilateral, other canals\n5. Complications from CRP eg: nausea, vomiting, canalith jam\n6. Cannot read the questionaire'}, 'identificationModule': {'nctId': 'NCT02701218', 'briefTitle': 'BPPV With CRP: Single Versus Multiple Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Comparison of the Treatment Outcomes of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) With Canalith Repositioning Procedure (CRP): Single Versus Multiple Cycles', 'orgStudyIdInfo': {'id': 'ENT-2558-03601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single cycle', 'description': 'single cycle of canalith repositioning procedure', 'interventionNames': ['Procedure: Canalith repositioning procedure']}, {'type': 'EXPERIMENTAL', 'label': 'multiple cycles of CRP', 'description': 'multiple cycles of canalith repositioning procedure CRP will be stopped if 1) no nystagmus and vertigo in all positions 2) complications exited 3) stable nystagmus in the 2 last cycles', 'interventionNames': ['Procedure: Canalith repositioning procedure']}], 'interventions': [{'name': 'Canalith repositioning procedure', 'type': 'PROCEDURE', 'otherNames': ["Epley's maneuver"], 'description': 'Canalith repositioning procedure; single or multiple cycles', 'armGroupLabels': ['Single cycle', 'multiple cycles of CRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suwicha I Kaewsiri, MD', 'role': 'CONTACT', 'email': 'suwicha.kaewsiri@cmu.ac.th', 'phone': '66-816802036'}, {'name': 'Sanathorn Chowsilpa, MD', 'role': 'CONTACT', 'email': 'sanathornch@hotmail.com', 'phone': '66-53935562'}], 'facility': 'Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Suwicha I Kaewsiri, MD', 'role': 'CONTACT', 'email': 'suwicha.kaewsiri@cmu.ac.th', 'phone': '66-816802036'}, {'name': 'Sanathorn Chowsilpa, MD', 'role': 'CONTACT', 'email': 'sanathornch@hotmail.com', 'phone': '66-53935562'}], 'overallOfficials': [{'name': 'Suwicha I Kaewsiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otolaryngology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Suwicha Isaradisaikul Kaewsiri', 'investigatorAffiliation': 'Chiang Mai University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-07-27', 'type': 'RELEASE'}, {'date': '2021-08-20', 'type': 'RESET'}, {'date': '2022-07-13', 'type': 'RELEASE'}, {'date': '2023-05-11', 'type': 'RESET'}, {'date': '2023-08-29', 'type': 'RELEASE'}, {'date': '2024-03-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Suwicha Isaradisaikul Kaewsiri, Principal Investigator, Clinical Professor, Chiang Mai University'}}}}