Could lowering high blood pressure be as simple as stimulating your ear?
A small device that gently stimulates nerves through the ear could offer a new way to tackle stubborn high blood pressure. In a clinical trial of 63 patients already taking medication, the treatment proved safe, easy to use at home, and well tolerated. Although it did not significantly outperform a placebo overall, patients with more severe hypertension showed promising reductions in blood pressure.
Key points
- A clinical trial tested a handheld device that sends mild electrical pulses to nerves in the ear to treat high blood pressure.
- The treatment was safe and well tolerated, but it did not significantly lower blood pressure across all 63 participants compared with a sham device.
- A planned subgroup analysis found greater blood pressure reductions in patients who started the trial with more severe hypertension.
A small handheld device that delivers gentle electrical pulses through the ear could offer a new way to treat hard-to-control high blood pressure, according to a clinical trial led by researchers at Queen Mary University of London. The results were published in Hypertension, a journal of the American Heart Association.
The SCRATCH-HTN trial enrolled 63 people with uncontrolled hypertension, all of whom were already taking at least one blood pressure medication. Participants were randomly assigned to active nerve stimulation or a sham device for comparison.
How the device works
The treatment uses transcutaneous autonomic neuromodulation (tAN), which aims to influence the autonomic nervous system, the nerve network that automatically controls heart rate, digestion and blood pressure. The device, developed by Afferent Medical Solutions, uses two small clips placed on the tragus, the cartilage flap just in front of the ear canal.
Participants used the device for 30 minutes daily during the first two weeks, then once a week for the following 10 weeks. Researchers reported that the treatment was safe and generally comfortable, and that most participants followed the schedule, suggesting it could be practical for home use.
Although the trial did not achieve significance across the broad unselected group, those with more severe hypertension exhibited a clear blood pressure reduction in the active group compared to sham.
— Dr. Ajay Gupta
Results and next steps
Across the full study population, researchers found no statistically significant difference in blood pressure changes between the active and sham groups. However, a prespecified subgroup analysis found a greater reduction among patients who entered the trial with more severe hypertension when they received active stimulation.
The researchers said the trial was relatively small and the subgroup findings need confirmation in larger studies. Dr. Ajay Gupta, chief investigator and clinical reader at Queen Mary University of London, called it an exciting, highly patient-acceptable technology that could ultimately provide a cheap, scalable solution for millions.
