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Can a gentle ear zap teach babies to swallow?

NCT ID NCT07802301

Disease control Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing whether a gentle electrical stimulation on the ear, called taVNS, paired with mouth and tongue exercises can help infants with severe swallowing difficulties. The trial will include 12 infants in the NICU who have trouble sucking and swallowing. Over three weeks, they will receive the stimulation twice daily during feeding therapy. The study will measure changes in swallowing mechanics, sucking strength, and how much they can feed by mouth, while also checking for safety issues like slow heart rate.

What this could mean

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

Active substance
Transcutaneous auricular vagus nerve stimulation (taVNS) paired with an oral sensorimotor training protocol
What this could lead to
If it works, this pairing could offer a drug-free way to improve swallowing and feeding in infants with severe dysphagia, potentially reducing the need for feeding tubes.
What could go wrong
This is a very small early trial with only 12 infants, so results may not apply broadly. The stimulation is experimental and could cause side effects like bradycardia, though safety is being closely monitored.

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 12 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 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

Up to 6 months

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: * Infants ≥37 weeks post-menstrual age * Diagnosed with dysphagia and significant sucking/swallowing impairment * Limited oral feeding ability * Admitted to NICU Exclusion Criteria: * Cardiomyopathy * Unstable bradycardia * Significant respiratory support requirement * Absence of gag reflex * Inability to manage secretions * Infants of poorly controlled diabetic mothers

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders eating disorder Feeding and Eating Disorders

As listed by the trial registrant

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

Dysphagia Feeding and eating disorders of infancy Swallowing disorders

How to take part

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  1. The official record

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