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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)

Recruitingn/aAges 14 Years - 35 YearsAllSimonetti Giacomo
NCT07072689 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: Population 1: * Informed Consent signed by the subject/legal representative * 14-20 years of age * Clinical indication to receive a 24-h ABPM measurement * Functional internet phone connection * Negative pregnancy test, ongoing anti-conceptive treatment or declaration of the subject not being pregnant Population 2: * 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 Population 3 * 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 Exclusion Criteria for both population 1, 2 and 3: * 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
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What it tests

  • Not listed
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Where

2 sites
Ente Ospedaliero Cantonale
Bellinzona, Switzerland
Geneva University Hospitals (HUG)
Geneva, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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