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

This study has been terminated.
(Inadequate recruitment, investigator left institution)
Sponsor:
Information provided by (Responsible Party):
Lawrence Schiller, Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01378351
First received: June 21, 2011
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Dysfunction of Vestibular System
Nausea Persistent
Vomiting
 Other: Questionnaire survey

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Improvement of nausea and vomiting [ Time Frame: 1 to 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Associated symptoms [ Time Frame: 1 to 2 months ] [ Designated as safety issue: No ]
  • Alternate diagnoses [ Time Frame: 1 to 2 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Questionnaire survey
    Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Lawrence Schiller, MD, Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01378351     History of Changes
Other Study ID Numbers: 011-085
Study First Received: June 21, 2011
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013