Vagal stimulation for Postural Orthostatic Tachycardia Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oklahoma Clinical and Translational Science Institute, Oklahoma City, OKPostural Orthostatic Tachycardia SyndromeVagal stimulation - Device
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Postural Orthostatic Tachycardia Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 minute

5 minute
Heart rate variability

Trial Safety

Safety Progress

1 of 3

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Trial Design

2 Treatment Groups

Vagal stimulation
1 of 2
Sham stimulation
1 of 2

Active Control

Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Vagal stimulation · Has Placebo Group · N/A

Sham stimulation
Device
ShamComparator Group · 1 Intervention: Sham stimulation · Intervention Types: Device
Vagal stimulation
Device
ActiveComparator Group · 1 Intervention: Vagal stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 minute

Who is running the clinical trial?

University of OklahomaLead Sponsor
426 Previous Clinical Trials
98,172 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
88 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,623 Previous Clinical Trials
47,121,687 Total Patients Enrolled
10 Trials studying Postural Orthostatic Tachycardia Syndrome
410 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Stavros Stavrakis, MDStudy DirectorUniversity of Oklahoma
3 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
30 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 18 and 80 years old, regardless of your gender.
You may participate in the study if you are a healthy person or if you have a condition called POTS, which means your heart rate increases by more than 30 beats per minute within 10 minutes of standing up. You should not have a significant drop in blood pressure and your symptoms should have lasted for more than 6 months. You should not have any other medical conditions that could cause your fast heart rate when standing up.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Oklahoma Clinical and Translational Science Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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