Vestibular Dysfunction as a Cause of Chronic Nausea & Vom... | NCT01378351

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

NCT01378351

Sponsor

Baylor Research Institute

Status

Terminated

Last Update Posted

Aug 26, 2013Estimated

Enrollment

2Actual

Phase

Not provided

Conditions

Dysfunction of Vestibular System
Nausea Persistent
Vomiting

Interventions

Questionnaire survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inadequate recruitment, investigator left institution

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 21, 2011

First Submission Date that Met QC Criteria

Jun 21, 2011

First Posted Date

Jun 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2013

Last Update Posted Date

Aug 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire survey	Other	Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of nausea and vomiting		1 to 2 months

Secondary Outcomes

Measure	Description	Time Frame
Associated symptoms		1 to 2 months
Alternate diagnoses		1 to 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatient gastroenterology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence Schiller, MD	Baylor Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baylor University Medical Center		Dallas	Texas	75246	United States

Condition Browse Module

MeSH Terms

ID	Term
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided