Dysfunction of Vestibular SystemNCT01378351
Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey
An observational study of Dysfunction of Vestibular System and Nausea Persistent, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Dysfunction of Vestibular System, Nausea Persistent, Vomiting
- What is being tested?
- Questionnaire survey
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient gastroenterology clinic
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Unable to complete questionnaire survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Study
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.
Read the 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.
- Being tested
- Questionnaire survey
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire surveyOther
Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of nausea and vomiting
Measured: 1 to 2 months
Secondary outcomes (2)
Associated symptoms
Measured: 1 to 2 months
Alternate diagnoses
Measured: 1 to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Inadequate recruitment, investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunction of Vestibular SystemStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Schiller, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378351
- Sponsor's protocol ID
- 011-085
- Status last verified
- Aug 2013
- First submitted
- 21 Jun 2011
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Study
- ClinicalTrials.gov ID
- NCT01378351
- Acronym / sponsor ID
- 011-085
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment, investigator left institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient gastroenterology clinic
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Unable to complete questionnaire survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire surveyMailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses. | Other | – |
Primary outcome
Improvement of nausea and vomiting
Time frame: 1 to 2 months
2 secondary outcomes
Associated symptoms
Time frame: 1 to 2 months
Alternate diagnoses
Time frame: 1 to 2 months
Results and safety
The study was stopped early (reason given: Inadequate recruitment, investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Schiller, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysfunction of Vestibular System and Nausea Persistent, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate recruitment, investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of nausea and vomiting (time frame: 1 to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.