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Not yet recruitingNAINTERVENTIONAL

Acute Cardiovascular Effects of Transcutaneous Auricular Vagus Nerve Stimulation

This study is exploring a new way to help control blood pressure and heart rate using a gentle electrical stimulation applied to a nerve in the ear. This method is called transcutaneous auricular vagus nerve stimulation (taVNS). Researchers want to find out if this stimulation can make an immediate, noticeable difference in healthy young adults. Conditions like high blood pressure often start with small changes in how the body controls the heart, so understanding how taVNS affects these early changes could be important. The study aims to accurately measure any changes in heart rate and blood pressure, checking if the stimulation helps to keep the heart working well and if it could prevent future heart problems.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Northumbria University
Enrolment target
20
Start
01 Mar 2026
Estimated completion
01 Dec 2027

What is this study about?

This research is looking into how a gentle electrical stimulation to a nerve in your ear might affect your heart and blood pressure. It's called 'vagus nerve stimulation' (taVNS) and it's a non-invasive way to try and improve how your body controls your heart.

Heart and blood pressure problems are very common, and often start with subtle changes in how our body regulates itself – a system called the 'autonomic nervous system'. This system has two main parts: one that revs things up and one that calms things down (the vagus nerve is part of the calming system). When these two parts are out of balance, it can lead to issues like high blood pressure over time. We know that things like stress, poor diet, and not enough exercise can throw this balance off, even in healthy young people.

The study wants to see if this gentle stimulation can help bring the autonomic nervous system back into balance quickly. By seeing how it affects healthy young adults, researchers can get a clear picture of what the stimulation does without other health conditions getting in the way. This early information is really important because it helps scientists understand if taVNS could be a useful tool to prevent heart problems in the future, by helping to keep the heart and blood pressure healthy from a young age.

Key takeaways

  • This study explores a gentle electrical ear stimulation to improve heart health.
  • It aims to balance the body's natural control system for heart rate and blood pressure.
  • Healthy young adults are participating to understand basic effects without other conditions.
  • The study uses 'sham' stimulation to ensure accurate results.
  • Findings could help prevent heart problems in the future.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 45 years old. You should not have any known major health conditions like heart disease, diabetes, or nerve problems. Your blood pressure should be normal, and your body weight should be within a healthy range.

You cannot join if you are pregnant or breastfeeding, or if you have an electronic medical device like a pacemaker. You also can't be taking medications that affect your heart or nerves. Anyone involved in another medical study or those with certain ear/skin conditions in the area where the stimulation would be applied will not be able to participate. If you have had very low heart rate or fainting spells, you also won't be able to join.

The research team will carry out some checks to make sure this study is safe and suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 45 years old?
  2. Do you have a normal blood pressure?
  3. Do you have good general health, without major heart or nerve conditions?
  4. Are you not pregnant or breastfeeding?
  5. Do you not have any electronic medical devices, like a pacemaker?
  6. Are you able to visit the clinic multiple times for the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a short period and will visit the clinic several times. On each visit, you will have a small device placed on your ear that delivers gentle electrical stimulation. You will experience three different types of stimulation at different visits: the actual stimulation, a 'sham' stimulation that feels similar but doesn't do anything, and another 'sham' that is very mild. You won't know which one you are receiving on any given day. Throughout these sessions, your blood pressure, heart rate, and other heart-related measurements will be continuously monitored. You should not be taking any medication that affects your heart or nerves before and during the study. The total duration of your participation will involve a few visits to the clinic, each lasting a specific amount of time for the stimulation and measurements.

Potential risks and benefits

The main benefit of taking part is contributing to scientific knowledge about how vagus nerve stimulation might help keep hearts healthy. This could lead to new ways to prevent heart problems in the future. Potential risks are generally mild and might include slight skin irritation where the device is placed or a feeling of tingling from the stimulation itself. These effects are usually temporary. You are free to withdraw from the study at any time, for any reason, without telling us why. Your decision will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Northumbria University
    Verified postcode
    Newcastle upon Tyne, United Kingdom

Common questions

What is 'vagus nerve stimulation'?

It's a gentle electrical current applied to a nerve in your ear to see if it can help balance your body's control system for your heart and blood pressure.

Will I feel anything during the stimulation?

You might feel a mild tingling sensation where the small device is placed on your ear.

Is this a new treatment?

This study is research to understand how the stimulation works. It's not a treatment yet, but could help develop future treatments.

What is a 'sham' condition?

A 'sham' condition is like a dummy treatment. It helps researchers compare the real stimulation's effects to what happens when no active stimulation is given, without you knowing the difference.

How long will each visit take?

Each visit will involve preparation, the 60-minute stimulation, and measurements, so the full details will be explained by the study team.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Acute Cardiovascular Effects of Transcutaneous Auricular Vag…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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