Study evaluating the blood pressure lowering efficacy and safety of a novel self-administered device-based treatment (by stimulating nerves that control blood pressure) in participants with uncontrolled hypertension.
High blood pressure is a leading cause of heart disease and strokes. While many people take daily medication, many still struggle to bring their readings down to a safe level. Researchers at Queen Mary University of London are testing a new non-drug treatment to help. The brain manages blood pressure through a network of nerves. This trial tests a small, battery-operated device that clips to the front of the ear. It sends gentle, mild electrical pulses through the skin to help calm the nerves that affect blood pressure. Participants will use the device at home for 30 minutes a day for two weeks, and then once a week for 10 weeks. Two-thirds of participants receive an active device, and one-third receive an inactive dummy device. The team will closely check your blood pressure throughout to see if this treatment is safe, comfortable, and helpful.
At a glance
What is this study about?
High blood pressure (hypertension) puts constant strain on your blood vessels and heart. Over time, this raises your risk of serious illness, such as heart attacks and strokes. While there are many blood pressure tablets available, they do not work well enough for everyone. For people whose readings stay high despite taking medication, doctors urgently need new and better options.
Your brain controls your blood pressure by sending signals through your nervous system. In many people with high blood pressure, these nerve signals become overactive or unbalanced. Researchers believe that gently stimulating certain sensory nerves can send calming messages back to the brain, helping to lower blood pressure naturally.
This study tests a small device similar to machines used for gentle pain relief. It clips onto the front part of the ear (the tragus) and delivers very weak electrical pulses through the skin. Researchers want to see if using this device at home is practical, safe, and effective at lowering blood pressure alongside standard medication.
Key takeaways
- Tests a simple, clip-on ear device designed to gently stimulate nerves that help control blood pressure.
- Aimed at adults aged 18 to 79 whose blood pressure remains high despite taking tablets.
- Used at home for 30 minutes daily for two weeks, then once weekly for 10 weeks.
- You will be randomly assigned to receive either the active device or an inactive dummy version.
- Participation is voluntary, and you can withdraw at any time without affecting your NHS care.
Who may be eligible?
This study is open to adults aged between 18 and 79 who have high blood pressure that is not fully controlled. You must already be taking between one and four blood pressure medicines, and your doses must remain unchanged during the study.
To be eligible, you also need to have at least one other related health factor. This includes having a higher body weight (a BMI over 30 or a larger waist size), having type 2 diabetes managed without insulin injections, or having a resting heart rate of 70 beats per minute or higher.
You will need to wear a 24-hour blood pressure monitor to confirm your readings meet the trial requirements. You also need a good understanding of English so you can comfortably read the trial instructions and fill in the study forms.
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.
- Are you between 18 and 79 years old?
- Do you have a diagnosis of high blood pressure?
- Are you currently taking between 1 and 4 blood pressure medications?
- Is your daytime blood pressure still higher than ideal (around 135/85 mmHg or higher)?
- Do you have type 2 diabetes (not on insulin), a resting pulse of 70+ bpm, or carry extra weight?
- Can you comfortably read and understand written English?
What does participation involve?
Taking part lasts around 12 to 14 weeks. You will start with a screening visit where doctors check your medical history, measure your resting heart rate, and give you a 24-hour blood pressure monitor to wear. If you join, you will be randomly chosen to receive either an active device or an inactive dummy device. Neither you nor the study team will know which one you have received.
You will be shown how to use the device safely at home. You will use it for 30 minutes every day for the first two weeks, and then 30 minutes once a week for the next 10 weeks. You will attend regular check-ups at the clinic so the research team can assess your blood pressure and general health. You must continue taking your usual prescribed blood pressure medications throughout the trial.
Potential risks and benefits
Locations (7)
- The Royal London HospitalApproximateLondon, England
- University College London Hospitals NHS Foundation TrustCity onlyLondon, England
- Homerton University Hospital NHS Foundation TrustCity onlyLondon, England
- Imperial College Healthcare NHS TrustCity onlyLondon, England
- St George's University Hospitals NHS Foundation TrustCity onlyLondon, England
- Royal Free London NHS Foundation TrustUnverifiedLondon, England
- Broomfield HospitalUnverifiedChelmsford, England
Common questions
Does the ear device hurt?
No. The device uses very mild electrical pulses. Most people only feel a light, harmless tingling sensation where the clip touches the ear.
Will I need to stop taking my regular blood pressure pills?
No. You must continue taking your usual prescribed tablets at the same dose throughout the entire study.
Can I choose whether I get the real device or the dummy device?
No. A computer randomly decides who gets the active device and who gets the inactive dummy device, giving a fair test of whether the treatment works.
Do I have to pay for the device or the clinic visits?
No. The study device, check-ups, and tests are provided free of charge through the research programme funded by the National Institute for Health and Care Research (NIHR).
What happens if my blood pressure spikes during the study?
The study team will monitor your blood pressure carefully. If your readings go beyond safe limits, the doctors will step in right away to adjust your care.
How to find out more
Ajay Gupta
Always speak to your GP or specialist before deciding to take part in a study.
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