Clinical Research Directory

A Multi-centre Study Evaluating the Performance and Acceptance of the Hilo Band Cuffless Blood Pressure Medical Device in the Normo-, Hypo- and Hyper-tensive Young Population: a Comparison With the 24-h Ambulatory Blood Pressure Monitoring (ABPM)

Sponsor: Simonetti Giacomo

Summary

Hypertension is one of the main risk factors for the onset of cardiovascular diseases. It is often silent, and most individuals are unaware they have it. The 24-hour Ambulatory Blood Pressure Monitoring (24-hour ABPM) device allows for continuous blood pressure (BP) monitoring over a 24-hour period and is currently considered the gold standard for diagnosing hypertension. However, it is expensive, time-consuming for healthcare personnel, bulky, and often uncomfortable to wear-especially during the night. Recently, other BP monitoring devices have entered the market. One of them is the Aktiia bracelet, renamed as Hilo band as of 8 april 2025, (Hilo band SA, Neuchâtel, Switzerland), CE-marked, which estimates BP and heart rate using a pulse wave analysis (PWA) technique. Hilo band is non-invasive, comfortable to wear, and allows for long-term BP monitoring. Especially in adolescents, BP monitoring might present a special challenge due to high physical activity and often low compliance. Wearable technologies like Hilo band could offer an interesting alternative to the traditional 24-h ABPM. Results in young active adults and adolescents might be different comparing between Hilo and the 24-h ABPM and need to be assessed. Furthermore, adolescents often dislike the 24-h ABPM beacuse of the discomfortable BP cuff (specially during the night) and the stigmatic effect of the 24-h ABPM at school/work. To conclude, there is a need especially in young people of comfortable, precise and user-friendly technique for long term BP measurement and monitoring. However, there is insufficient data to support the use of Hilo band in healthcare settings for the diagnosis and monitoring of hypertension. In one study, Hilo band was compared to the 24-hour ABPM only for daytime BP readings in a population enrolled in a cardiac rehabilitation program, and thus was not tested in apparently 'healthy' individuals who may be hypertensive. Another study assessed Hilo band's performance compared to double auscultation in older adults aged 65 to 85 years in different body positions (sitting, standing, and lying down); therefore the young population and adolescents were not considered. In our research project, we aim to evaluate the performance of Hilo band compared to 24-hour ABPM in a young population (including adolescents), considering both daytime and nighttime blood pressure measurements.

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