Lifestyle & Healthresearch summary
Ear-clip device shows promise for severe uncontrolled high blood pressure in a small trial
A handheld device that sends gentle pulses through the ear was safe and easy to use at home, and it lowered pressure more in patients with severe hypertension.
This article is general information, not medical advice. Talk to a doctor or another qualified professional about your own situation.
A small device with a possible new role
A small device delivering gentle electrical pulses through the ear could offer a new approach to treating stubborn high blood pressure [1]. It matters most to people whose readings stay above recommended targets even while they receive treatment, and a substantial number of patients are in that position [1].
In the clinical trial, the technology proved safe, well tolerated, and practical for patients to use at home [1]. Researchers at Queen Mary University of London led the trial [1].
How the treatment works
The experimental treatment uses a technique called transcutaneous autonomic neuromodulation (tAN), which aims to influence the autonomic nervous system [1]. That system automatically controls essential bodily functions, including heart rate, digestion, and blood pressure [1].
Afferent Medical Solutions developed the handheld device [1]. It uses two clips on the tragus that deliver gentle electrical stimulation, and patients can give themselves the treatment without visiting a clinic [1].
How the trial was run
The trial enrolled 63 people with uncontrolled hypertension [1]. All of them were already taking at least one medication to lower blood pressure but remained above recommended levels [1]. The National Institute for Health and Care Research (NIHR) funded the work [1].
Participants were randomly divided into an active nerve stimulation group and a group using a sham device as a comparison [1]. They used the device for 30 minutes daily during the first two weeks, then once per week for the following 10 weeks [1]. Most participants followed the prescribed schedule, and adherence was high [1][2].
What the results show
Across the entire study population, there was no statistically significant difference in blood pressure change between active stimulation and the sham device [1]. The active device did not produce a statistically significant improvement over sham treatment across all participants [2].
A prespecified subgroup analysis found a greater blood pressure reduction with active nerve stimulation than sham among patients who entered the trial with more severe hypertension [1]. The results were published in Hypertension, a journal of the American Heart Association [1].
What the lead investigator says
Dr. Ajay Gupta is the chief investigator, a clinical reader at Queen Mary University of London, and a consultant physician at Barts Health NHS Trust [1]. Gupta said the technology is exciting, highly patient-acceptable, and could ultimately provide a cheap, scalable solution for millions [1].
Gupta also said the trial was the first and most thorough study of its kind [1]. He said it points to new research directions on whether non-invasive neuromodulation can benefit particular groups with uncontrolled hypertension [1].
Limits of the findings
The trial was relatively small, and the subgroup results require confirmation in larger studies before conclusions about effectiveness can be drawn [1]. Researchers say larger clinical trials will be essential to confirm the encouraging results in severe hypertension and identify which groups could benefit most [1].
What it means for you
High blood pressure is a major contributor to cardiovascular disease and increases the risk of heart attacks and strokes [1]. Uncontrolled high blood pressure can also damage blood vessels and raise the risk of heart failure and kidney disease [2].
If your blood pressure stays above target despite medication, this device is an experimental option that has been tested only in a small trial [1]. Across all participants it did not beat a sham device, so its effectiveness is not established [1]. The signal of benefit appeared in people with more severe hypertension, and that result awaits confirmation in larger studies [1].
Sources
- Could lowering high blood pressure be as simple as stimulating your ear? — ScienceDaily
- Ear Stimulation May Control High Blood Pressure — Knowridge Science Report
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