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Ear stimulation device may help control blood pressure during heart surgery

NCT ID NCT06784583

Disease control Sponsor: Guozhe Sun Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether a device that gently stimulates a nerve in the ear (vagus nerve) can help control blood pressure during heart stent placement. 480 adults with coronary artery disease and high blood pressure were randomly assigned to receive either real or sham stimulation. Researchers compared blood pressure changes between the two groups during the procedure.

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 device
What this could lead to
If it works, this could offer a non-drug way to manage blood pressure spikes during heart stent procedures.
What could go wrong
This is a small, completed study, so results may not apply to everyone. The effect on long-term outcomes is unknown.

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

480 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2025

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 70 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: * Ages between 18 and 70 years old, regardless of gender * Patients with indications for coronary artery stent implantation * hypertension history * Voluntarily participate and sign an informed consent form Exclusion Criteria: * Patients with acute myocardial infarction * Patients with heart failure of NYHA class III - IV * Patients with atrial fibrillation (indicated by definite medical history or electrocardiogram on admission) * Patients with a medical history of hyperthyroidism * Patients with subclavian artery occlusion (indicated by definite medical history or a difference in systolic blood pressure of more than 20 mmHg between the two upper limbs) * With an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m² on admission * Patients with infections and fever * Patients who are unable to cooperate due to mental and psychological disorders (such as mania, depression) * Patients with tinnitus and vertigo * Pregnant women or patients who are attempting to get pregnant * Patients participating in clinical trials of other drugs or medical devices * Patients deemed unsuitable by the researchers to participate in this clinical trial

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Conditions

The condition(s) this trial relates to.

coronary artery disorder hypertensive disorder

As listed by the trial registrant

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

Coronary artery disease Hypertension

Contacts and locations

Locations

  • First Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

More trials for these conditions

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