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Vagal Nerve Stimulation for POTS

N/A
Recruiting
Research Sponsored by University of Oklahoma
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
Must not have
Hypertension (>150 mmHg systolic and >100 mmHg diastolic) based on history or findings at screening
Currently pregnant women or women planning on becoming pregnant ≤ 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minute

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.
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.
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 below
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is higher than 150/100 mmHg.
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I am currently pregnant or planning to become pregnant within the next 3 months.
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I have a significant immune or blood disorder.
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I have had surgery to remove part of my vagus nerve.
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My blood pressure drops significantly when I stand up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minute
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minute for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
473 Previous Clinical Trials
93,601 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
3,935 Previous Clinical Trials
47,792,251 Total Patients Enrolled
12 Trials studying Postural Orthostatic Tachycardia Syndrome
880 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Stavros Stavrakis, MDStudy DirectorUniversity of Oklahoma
6 Previous Clinical Trials
274 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
5 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

Vagal stimulation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05043051 — N/A
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Vagal stimulation, Sham stimulation
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Vagal stimulation Highlights & Side Effects. Trial Name: NCT05043051 — N/A
Vagal stimulation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05043051 — N/A
Postural Orthostatic Tachycardia Syndrome Patient Testimony for trial: Trial Name: NCT05043051 — N/A
~6 spots leftby Feb 2025
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