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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Population 2

No indications for blood pressure measurements

No interventions assigned to this group

Population 1

Indications to receive blood pressure measurement of 24-hours

No interventions assigned to this group

Eligibility Criteria

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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

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes