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Can a fake vagus nerve device fool the Body's inflammation response?

NCT ID NCT07791290

Knowledge-focused Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers are testing whether a sham version of the Vagustim ear device can act as a believable placebo in vagus nerve stimulation studies. The trial enrolls 20 healthy adults matched by age and sex. Participants receive either real or sham stimulation, and researchers measure blood levels of TNF, an inflammation marker. The goal is to validate the sham method so future trials can more accurately test taVNS for inflammatory conditions.

What this could mean

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

Active substance
Vagustim transcutaneous auricular vagus nerve stimulation device
What this could lead to
If the sham method works as a placebo, future trials can more reliably test whether vagus nerve stimulation truly reduces inflammation.
What could go wrong
This is a small pilot study with 20 healthy adults. The sham may not fully mimic the real device's sensation, and results may not apply to people with inflammatory conditions.

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 20 people

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

Started

Jun 2025

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

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age greater than or equal to 18 years 2. Capable of giving informed consent or have an acceptable surrogate capable of giving consent on the participant's behalf. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Participants or guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 2. Any known inflammatory condition (e.g., SLE) or other chronic condition including kidney disease (exceptions: temporary urinary conditions, including urinary tract infection (UTI), microscopic hematuria, etc. ) 3. History of cardiac disease (arrhythmias, structural/functional abnormalities). 4. Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators). 5. Chronic rash or skin breakdown of the left ear at the cymba concha. 6. Pregnancy or breast feeding.

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As listed by the trial registrant

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

Healthy controls group - age and sex-matched

How to take part

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  1. The places running it

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

  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Cohen Children's Medical Center, Pediatric Nephrology

    RECRUITING

    New Hyde Park, New York, 11042, United States

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