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Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey

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ClinicalTrials.gov Identifier: NCT01378351
Recruitment Status : Terminated (Inadequate recruitment, investigator left institution)
First Posted : June 22, 2011
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Dysfunction of Vestibular System Nausea Persistent Vomiting Other: Questionnaire survey

Detailed Description:

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.

The 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.


Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Study
Study Start Date : June 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Other: Questionnaire survey
    Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.


Primary Outcome Measures :
  1. Improvement of nausea and vomiting [ Time Frame: 1 to 2 months ]

Secondary Outcome Measures :
  1. Associated symptoms [ Time Frame: 1 to 2 months ]
  2. Alternate diagnoses [ Time Frame: 1 to 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatient gastroenterology clinic
Criteria

Inclusion Criteria:

  • Clinical symptoms of nausea and vomiting for at least 4 weeks
  • 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

Exclusion Criteria:

  • Pregnancy
  • Unable to complete questionnaire survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378351


Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Lawrence Schiller, MD Baylor Health Care System

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01378351     History of Changes
Other Study ID Numbers: 011-085
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms