Compares a wristband blood pressure device with 24-hour monitoring in young people
Compares a cuffless wristband with 24-hour blood pressure monitoring in young people.
Key facts
- Who runs it
- Simonetti Giacomo
- Where
- Bellinzona and Geneva, SwitzerlandSee the 2 sites
- Trial code
- Registry title
- 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)
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 1 Dec 2025
- Expected to end
- 1 Dec 2028
- Type of study
- Observational, 3 groups
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young people aged 14 to 35 to test a wrist blood pressure band against a 24-hour blood pressure monitor.
- Age
- 14 to 35 years. Population 1: 14-20 years. Populations 2 and 3: 21-35 years.
- Sex
- All sexes can join.
- Disease stage
- Populations 1 and 2 need a clinical reason to have 24-hour blood pressure monitoring. Population 3 does not list this.
Main reasons for not taking part
- Allergy to silicone
- Atrial fibrillation or other irregular heartbeat (arrhythmia)
- Conditions that lower blood flow in the hands, such as Raynaud's disease, diabetes or kidney problems (eGFR < 30mL / min / 1.73 m2)
- Pregnancy
- Skin disease, injury or swelling at the wrist, or a wrist wider than 22 cm (8.7 in)
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- Allergies to silicone
- Subjects with arrhythmia
- Exfoliative skin diseases and lymphoedema or damaged/injured skin at the wrist
- Individuals with lack of judgment/mental illness
- Pica disorder
- 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
- Atrial fibrillation
- 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
- Pregnant women
- Sleepwalking and severe insomnia
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 35 years old?
Where in Switzerland
- Ente Ospedaliero CantonaleBellinzona, SwitzerlandContact: Lisa Pedrotti, MScTaking people
- Geneva University Hospitals-HugGeneva, SwitzerlandContact: Belen Ponte Dr. medTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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 monitoring might present a special challenge due to high physical activity and often low compliance. Wearable technologies like Hilo band could offer an interesting alternative to the traditional 24-h ABPM. Results in young active adults and adolescents might be different comparing between Hilo and the 24-h ABPM and need to be assessed.
Furthermore, adolescents often dislike the 24-h ABPM beacuse of the discomfortable BP cuff (specially during the night) and the stigmatic effect of the 24-h ABPM at school/work.
To conclude, there is a need especially in young people of comfortable, precise and user-friendly technique for long term BP measurement and 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 BP 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); therefore the young population and adolescents were not considered.
In our research project, we aim to evaluate the performance of Hilo band compared to 24-hour ABPM in a young population (including adolescents), considering both daytime and nighttime blood pressure measurements.
The 3 groups in the trial
- Population 1
patients aged 14 to 20 years with an indication to undergo the 24-h ABPM
- Population 2
Patients aged 21 to 35 years with an indication to undergo 24-h ABPM
- Population 3
healthy volunteers aged 21 to 35 years
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Compares a wristband blood pressure device with 24-hour monitoring in young peopleGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07072689, who can take part
- Record updated
- 13 October 2026