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NCT03930914 · ClinicalTrials.gov registry record · NA

Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

A NA study, sponsored by University of Oklahoma.

Completed
Registry status
NA
Development phase
5
Enrollment target

NCT03930914: Completed NA study, sponsored by University of Oklahoma.

NCT03930914 is a NA study that has completed, run by University of Oklahoma. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03930914, a NA study, has completed, sponsored by University of Oklahoma.

COMPLETED
Registry status
NA
Development phase
5 participants
Enrollment target

Study Summary

Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more. The investigator has shown that patients with POTS have higher cardiovascular and adrenergic activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are autoantibodies that have been suggested by a few reports of their presence in POTS, but their role different aspects of POTS is unknown. The study will look at the body's responses in patients with POTS. The crossover study design is to have half of the patients will start with sham followed by active stimulation and half will start by active followed by sham stimulation. It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS.

Primary Outcome

We will measure the average change in heart rate between supine and standing using continuous ECG after two and four months of daily vagal nerve stimulation

Interventions

  • DEVICE Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2019-11-04
Est. Completion 2021-12-07
Phase NA
University of Oklahoma

358 total trials

What the finished NCT03930914 record still lists

NCT03930914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device is the first listed.

NCT03930914 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03930914 about?

NCT03930914 is a clinical study titled "Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome". Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more. The investigator has shown that patients with POTS have highe...

What is the current status of trial NCT03930914?

This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2019-11-04. Estimated completion is 2021-12-07.

What interventions are being tested in trial NCT03930914?

The interventions under investigation include: Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device (DEVICE).

Who is sponsoring clinical trial NCT03930914?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03930914's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03930914, the US trial registry maintained by the National Library of Medicine. NCT03930914 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.