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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-80 years old, female or male
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minute
Awards & highlights
Study Summary
This trial will test if an autoimmune reaction is the cause of symptoms in some patients with POTS, and if electrical stimulation of the vagus nerve can help.
Who is the study for?
This trial is for adults aged 18-80 with Postural Tachycardia Syndrome (POTS), characterized by a rapid heartbeat upon standing, without other causes of orthostatic tachycardia. Healthy controls must be non-smoking and not on chronic medications. Excluded are those with recent heart attacks, significant immune or blood disorders, pregnancy, pacemakers or cochlear implants, severe hypertension, history of vagotomy.Check my eligibility
What is being tested?
The study aims to see if stimulating the vagus nerve can improve symptoms in POTS patients by potentially reducing autoimmune reactions and inflammation. Participants will receive either actual vagal stimulation or sham (fake) stimulation to compare effects.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally speaking, vagal stimulation might cause discomfort at the site of stimulation, changes in voice tone due to laryngeal muscle activation and possible temporary changes in heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 minute
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minute
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate variability
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Vagal stimulationActive Control1 Intervention
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
Group II: Sham stimulationPlacebo Group1 Intervention
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,843 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
63 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,514 Total Patients Enrolled
10 Trials studying Postural Orthostatic Tachycardia Syndrome
410 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Stavros Stavrakis, MDStudy DirectorUniversity of Oklahoma
5 Previous Clinical Trials
298 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
5 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and can follow the study's procedures and rules.My blood pressure is higher than 150/100 mmHg.I am currently pregnant or planning to become pregnant within the next 3 months.I either do not have health issues or have POTS with specific heart rate and blood pressure changes.I have not had a heart attack in the last 6 months.I am between 18 and 80 years old.I have a significant immune or blood disorder.I have had surgery to remove part of my vagus nerve.I am healthy, don't smoke, and take no chronic medications.My blood pressure drops significantly when I stand up.
Research Study Groups:
This trial has the following groups:- Group 1: Vagal stimulation
- Group 2: Sham stimulation
Awards:
This trial has 0 awards, including: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.
Postural Orthostatic Tachycardia Syndrome Patient Testimony for trial: Trial Name: NCT05043051 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial enlisting new participants at the present?
"As per the information on clinicaltrials.gov, this clinical trial is actively accepting participants. The initial posting date was January 14th 2022 with a most recent update of March 2nd 2022."
Answered by AI
Does the eligibility criteria for this trial encompass seniors aged 85 or older?
"The parameters of this clinical trial are set to allow patients aged between 18 and 80. However, there is a total of 386 medical studies available for those under the age of majority and 1071 resources aimed at seniors above 65 years old."
Answered by AI
Who has the credentials to join this medical study?
"To be a viable candidate for this trial, applicants must suffer from postural orthostatic tachycardia syndrome and have an age between 18 and 80. Currently, the enrolment goal is approximately 80 participants."
Answered by AI
How many individuals are participating in this clinical trial?
"Indeed, according to clinicaltrials.gov, the trial that was posted on January 14th 2022 is currently enrolling participants. 80 subjects are needed from a single institution for this research effort."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Florida
How old are they?
18 - 65
What site did they apply to?
Oklahoma Clinical and Translational Science Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I’m suffering with POTS and there are no health care providers that are experts in this field I. Miami. Looking for a study as well.
PatientReceived 1 prior treatment
I have tried medication that doesn’t work. I would love to reduce my pot’s symptoms and help doctors learn more about the disorder and help find ways to treat it.
PatientReceived 1 prior treatment
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