Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-25 @ 8:20 PM
Study NCT ID:
NCT01378351
Status:
TERMINATED
Last Update Posted:
2013-08-26
First Post:
2011-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Inadequate recruitment, investigator left institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-22', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of nausea and vomiting', 'timeFrame': '1 to 2 months'}], 'secondaryOutcomes': [{'measure': 'Associated symptoms', 'timeFrame': '1 to 2 months'}, {'measure': 'Alternate diagnoses', 'timeFrame': '1 to 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dysfunction of Vestibular System', 'Nausea Persistent', 'Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the accompanying symptoms, evaluation and management of patients with chronic vestibular dysfunction presenting with nausea and vomiting.', 'detailedDescription': 'Based on prior study, a significant portion of patients referred for refractory gastroparesis in fact have signs suggestive of vestibular dysfunction as the cause of chronic nausea and vomiting. Our prior retrospective study identified a population of said subjects.\n\nThe aim of this study is to further characterize the concomitant symptoms, course of diagnosis, treatment and long-term follow up (up to 5 yrs) of this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatient gastroenterology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical symptoms of nausea and vomiting for at least 4 weeks\n* Abnormal modified Fukuda stepping test on examination (\\>90 degree rotation from midline while marching in place for 60 seconds) or nystagmus or abnormal Rhomberg test\n\nExclusion Criteria:\n\n* Pregnancy\n* Unable to complete questionnaire survey'}, 'identificationModule': {'nctId': 'NCT01378351', 'briefTitle': 'Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Study', 'orgStudyIdInfo': {'id': '011-085'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire survey', 'type': 'OTHER', 'description': 'Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Lawrence Schiller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}