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Noninvasive Diagnostic Tests for Nausea
N/A
Waitlist Available
Led By Alan Bradshaw, Ph.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
normal control participants ages 8-17 who have no known gastrointestinal complications
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will study how well multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings can noninvasively characterize functional nausea in adolescents.
Who is the study for?
This trial is for children aged 8-17 who either experience functional nausea or are healthy controls without gastrointestinal issues. It excludes those with claustrophobia, cardiac arrhythmias, severe obesity, cyclic vomiting syndrome, gastroparesis, cancer, eating disorders, pregnancy or hyperglycemia.Check my eligibility
What is being tested?
The study aims to identify noninvasive markers of functional nausea using questionnaires and various recording techniques like EGG and MGG. Medications Ondansetron and Cyproheptadine will also be evaluated in this pediatric population.See study design
What are the potential side effects?
Potential side effects from the medications include headaches, constipation or diarrhea (Ondansetron), and drowsiness or dry mouth (Cyproheptadine). The recording procedures are generally safe but may cause discomfort due to lying still.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8-17 years old and do not have any known stomach or intestine problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Normal Slow Waves (PNSW)
Trial Design
5Treatment groups
Active Control
Group I: Moderately nauseatedActive Control5 Interventions
Functional nausea patients with a score of 5-6 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.
Group II: Severely nauseatedActive Control7 Interventions
Functional nausea patients with a score of 7-9 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar. Some patients will also be tested after receiving a one time dose of a 4mg or 8mg dependent upon age disintegrating tablet of ondansetron followed by a 2 day washout period prior to testing again after a 5 day maintenance dose of oral cyproheptadine 4mg twice a day.
Group III: Healthy ControlsActive Control5 Interventions
Healthy Volunteers with no known gastrointestinal complications will be given questionnaires and testing by electrogastrogram (EGG) and/or magnetogastrogram (MGG) after an overnight fast to determine nausea parameters. They will also have a electrocardiogram (EKG) and do some testing after being fed a protein bar.
Group IV: Non-nauseatedActive Control5 Interventions
Functional nausea patients with a score of 0-2 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.
Group V: Mildly nauseatedActive Control5 Interventions
Functional nausea patients with a score of 3-4 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,062 Total Patients Enrolled
1 Trials studying Nausea
Alan Bradshaw, Ph.D.Principal InvestigatorVanderbilt University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of heart rhythm problems and am not on blood thinners.You are very overweight and may not fit properly in the equipment used for the study.My child, aged 8-17, frequently experiences nausea without a clear cause.I am between 8-17 years old and do not have any known stomach or intestine problems.I do not have cyclic vomiting, gastroparesis, cancer, eating disorders, am not pregnant, and do not have high blood sugar.You feel very uncomfortable in tight or enclosed spaces and cannot remain still during the test.I have a healthy body but with known gut issues.
Research Study Groups:
This trial has the following groups:- Group 1: Moderately nauseated
- Group 2: Severely nauseated
- Group 3: Healthy Controls
- Group 4: Non-nauseated
- Group 5: Mildly nauseated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment enrolling participants who are at least thirty years old?
"Applicable individuals for this study must be between 8 and 17 years old. Patients under 18 have the opportunity to join 17 other trials, while those over 65 can select from 69 different studies."
Answered by AI
Is there still an opportunity for individuals to participate in this trial?
"As reported on clinicaltrials.gov, this trial is not currently in the process of enrolling patients; however, it was initially published on August 3rd 2018 and last updated April 1st 2022. Although there are no vacancies at present, 95 other studies have open recruitment opportunities."
Answered by AI
What maladies can be ameliorated by utilizing Mildly nauseated?
"Mildly nauseated is a therapeutic remedy for dealing with vasomotor rhinitis and its related symptoms, like conjunctivitis, pharmacotherapy, as well as seasonal allergic rhinitis."
Answered by AI
Am I eligible to enroll in the experiment?
"This clinical trial aims to involve 130 participants aged 8-17 who have experienced nausea. There is a need for children suffering from functional nausea as well as healthy subjects with no history of gastrointestinal issues."
Answered by AI
What is the aggregate enrollment of individuals in this clinical trial?
"This research study is temporarily not seeking out candidates. It was first listed on August 3rd 2018, and the most recent update happened April 1st 2022. For individuals looking for similar studies to enter, there are currently 74 trials recruiting patients with nausea and 21 clinical trials actively searching for mildly nauseous participants."
Answered by AI
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