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)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Evaluate the 24-hour performance of Hilo band in measuring diastolic and systolic blood pressure values in young subjects of 21-35 years of age. We will use the 24h ABPM as a reference method [Срок оценки: 24 hours]

Вторичные конечные точки (3)

• Assessing the consistency of the performance of Hilo band in measuring systolic and diastolic blood pressure values in young subject of 21-35 years of age over a 3-day period with the 24-h ABPM as a reference method [Срок оценки: 3 days]
• Evaluate the performance of Hilo band in effectively classifying hypertension in young subjects of 21-35 years of age with the 24-h ABPM as a reference method. [Срок оценки: 3 days]
• Evaluate the degree of satisfaction of the use of the Hilo band by study participants and physicians with the 24-h ABPM as a reference method. [Срок оценки: 3 days]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Швейцария · 1 центр

• Ente Ospedaliero Cantonale — Bellinzona

Идентификаторы

NCT: NCT07072689 · IPSI-HYPE-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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