Hilo band versus 24-hour ABPM in young people with high or normal blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center observational study evaluating the performance and acceptance of the Hilo band, a cuffless BP device, against the 24-hour ABPM in 40 participants aged 14 to 35. The study uses a non-interventional design to compare systolic and diastolic BP measurements from the Hilo band with those from ABPM over a 24-hour period. Participants include adolescents and young adults with a clinical indication for 24-hour BP monitoring, recruited at Bellinzona and Geneva. The aim is to assess accuracy, usability, and potential advantages of long-term, comfortable, cuffless monitoring in a real-world setting. Ethically approved and conducted in collaboration with SwissPedNet and the involved hospitals.

Why it matters

Who can join: the full rules

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

Where it's running

• Ente Ospedaliero Cantonale
  Bellinzona, Switzerland Recruiting
• Geneva University Hospitals (HUG)
  Geneva, Switzerland Recruiting

Study contacts

• Principal investigator: Giacomo Simonetti, Prof. Dr. med — Ente Ospedaliero cantonale (EOC)
• Study coordinator: Lisa Pedrotti, MSc
• Email: lisa.pedrotti@eoc.ch
• Phone: +41918119738

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.