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Can a zap to the ear tame sepsis?

NCT ID NCT03992378

Disease control Sponsor: University of Oklahoma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a mild electrical pulse to the ear (vagus nerve stimulation) can reduce inflammation and improve heart rate balance in people with septic shock. 34 participants will be randomly assigned to receive either active stimulation or a sham (placebo) for 4 hours, alongside standard care. The goal is to see if this approach lowers inflammatory markers and improves a sepsis severity score.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-level transcutaneous vagus nerve stimulation (a device that delivers mild electrical pulses to the ear)
What this could lead to
If it works, this could point toward a non-drug way to calm inflammation and improve outcomes in sepsis.
What could go wrong
This is a very early, small pilot study with only 34 participants. It tests a short 4-hour stimulation, so any benefits may be temporary or not seen at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Septic shock (meeting severe sepsis and having persistent systolic blood pressure \<90mmHg despite adequate fluid resuscitation). Exclusion Criteria: * Unilateral or bilateral vagotomy * History of myocardial infarction or stroke in the last 1 year * Recurrent vasovagal syncope * Sick sinus syndrome without pacemaker * Bifascicular heart block * 2nd or 3rd-degree heart block * Hypotension due to autonomic dysfunction * Pregnant women * Prisoners and patients with suicidal ideation

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

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