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Ear zaps aim to calm diabetic stomach troubles

NCT ID NCT06783504

Symptom relief Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests if a gentle electrical stimulation on the outer ear can activate the vagus nerve and reduce nausea, vomiting, and stomach discomfort in people with diabetes and gastroparesis. Sixty adults with both conditions will receive the treatment and report symptom changes. The goal is to improve symptom control without medication.

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 60 people

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

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 to 60 years

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: * Wiling to have one teaspoon (5 ml) of blood drawn. * Diagnosed with gastroparesis for twelve months or longer * Diagnosed with diabetes either Type 1 or Type 2 * Documented delayed gastric emptying (\>10% retention of the test meal at four hours) on a standardized scrambled-egg scintigraphy gastric emptying test performed in the last two years. * Upper GI endoscopy indicating no mechanical obstruction performed in the last five years. * Symptoms of nausea and vomiting consistent with clinical diagnosis of gastroparesis (as opposed to other causes of nausea and vomiting such as mechanical obstruction, acute viral illness, chemotherapy, psychogenic vomiting. * Documented Hb A1c within three months of screening or at the time of screening (\<=8.0) Exclusion Criteria: * Unable to provide consent * Pregnant females * Medical records indicate intestinal pseudo-obstruction * Diagnosed with cardiac arrhythmia * History of prior gastric surgery * History of vagotomy * History of organ transplantation * History of seizures * Diagnosed with primary swallowing disorders * Subjects who are dependent on drugs like Marinol for their condition * Those diagnosed with psychogenic vomiting and not related to gastroparesis * Medically unstable subjects * Those at high surgical risk * Subjects taking narcotic analgesics daily. * Those with poorly controlled diabetes mellitus (Hgb A1c\>8) within three months of screening or at the time of screening. * Subjects diagnosed with hemophilia, psoriasis vulgaris are excluded * Those having a cardiac pacemaker will be excluded from the study.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus gastroparesis

As listed by the trial registrant

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

Diabetes Gastroparesis

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

  • Indiana University Hospital

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.