A Single-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) (IPSI-HYPE-001)

Simonetti Giacomo

Status

Begins enrollment in 3 months

Conditions

Hypertension

Study type

Observational

Funder types

Other

Identifiers

NCT07072689

IPSI-HYPE-001

Details and patient eligibility

About

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 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 blood pressure 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 blood pressure and heart rate using a pulse wave analysis (PWA) technique. Hilo band is non-invasive, comfortable to wear, and allows for long-term blood pressure 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 blood pressure 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), and therefore did not include a younger population.

In our research project, we aim to evaluate the performance of Hilo band compared to 24-hour ABPM in a younger population, considering both daytime and nighttime blood pressure measurements.

Full description

This research project is a single-center non-interventional performance study of San Giovanni Hospital in Bellinzona comparing the systolic and diastolic blood pressure measurement of Hilo band with the systolic and diastolic blood pressure measurement of the 24-h ABPM of 40 young participants between 21 and 35 years of age.

Enrollment

40 estimated patients

Sex

All

Ages

21 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Population 2:

Informed Consent signed by the subject
21-35 years of age
Functional internet phone connection
Negative pregnancy test, ongoing anti-conceptive treatment or declaration of the subject not being pregnant

Population 1:

Informed Consent signed by the subject
21-35 years of age
Clinical indication for receiving a 24-hour blood pressure measurement
Functional internet phone connection
Negative pregnancy test, ongoing anti-conceptive treatment or declaration of the subject not being pregnant

Exclusion Criteria for both population 1 and 2:

Allergies to silicone
Atrial fibrillation
Subjects with arrhythmia
Patients suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula
Interarm Systolic Blood Pressure (SBP) difference over 10% or Diastolic Blood Pressure (DBP) difference over 10%
Arm paralysis
Amputated upper limb
Arm trembling or shivering
Upper arm circumference > 64 cm
Wrist circumference > 22 cm
Exfoliative skin diseases and lymphoedema or damaged/injured skin at the wrist
Pregnant women
Individuals with lack of judgment/mental illness
Sleepwalking and severe insomnia
Pica disorder