HypertensionIPSI-HYPE-001NCT07072689
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)
An observational study of Hypertension, run by Simonetti Giacomo at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Dec 2025to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This is a multi-centre non-interventional performance research project investigating the performance of Hilo band in three different study populations: population 1, 2 and 3. In population 1, we will recruit young participants between 14 and 20 years of age that come to San Giovanni Hospital in Bellinzona or to HUG with indication to receive a 24-hour ABPM. In population 2, we will recruit young participants between 21 and 35 years of age that come to San Giovanni Hospital in Bellinzona or to HUG with indication to receive a 24-hour ABPM. In population 3, we will recruit healthy, voluntary individuals between 21 and 35 years of age.
Who may be able to join
- 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
Show all 17Show fewer
- 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 join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Ente Ospedaliero Cantonale
Bellinzona
Lisa Pedrotti, MSc, +41918119738, lisa.pedrotti@eoc.ch
- Recruiting
Geneva University Hospitals (HUG)
Geneva
Belen Ponte Dr. med, 0795533245, belen.ponte@hug.ch
Floriane Vigano, floriane.vigano@hug.ch
About this study
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.
Read more
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.
Read the detailed description
This research project is a multi-center non-interventional performance study of San Giovanni Hospital in Bellinzona in collaboration with the Geneva University Hospitals (HUG) 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 14 and 35 years of age.
- Conditions
- Hypertension
- Keywords
- Aktiia, 24-h ABPM, hypertension, blood pressure, adolescents, Hilo, young population, EOC, HUG
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 24-hour performance of Hilo band in measuring diastolic and systolic blood pressure values in young subjects of 14-35 years of age. We will use the 24h ABPM as a reference method
To assess our primary endpoint, the 24-hour systolic and diastolic pressure averages (including waking and sleeping hours) of Hilo band will be compared to the 24-hour systolic and diastolic pressure averages of the 24-h ABPM, respectively. A similar performance of the two devices is defined as a standard deviation from the 24-hour (including waking and/or sleeping hours) average systolic and/or diastolic pressure values of maximum 10 mmHg, as reported in previous studies.
We will consider valid and include in the analysis 24-h ABPM recordings lasting ≥22 hours with ≥80% of successful readings, and cumulative recording gaps no greater than 2 hours.
On the other hand, Hilo band's blood pressure recordings are considered valid if at least 24 measurements are recorded during the 24 hours period.
Measured: 24 hours
Secondary outcomes (3)
Assessing the consistency of the performance of Hilo band in measuring systolic and diastolic blood pressure values in young subject of 14-35 years of age over a 3-day period with the 24-h ABPM as a reference method
The 72-hour systolic and diastolic pressure averages (including waking and sleeping hours) of Hilo band will be compared to the 24-hour systolic and diastolic pressure averages of the 24-h ABPM, respectively. A similar performance of the two devices is defined as a difference in the average 72-hour (for Hilo band) and 24-hours (for the 24-h ABPM) systolic and diastolic pressure values (including waking and sleeping hours) of up to 10 mmHg, as reported in previous studies.
We will consider valid and include in the analysis 24-h ABPM recordings lasting ≥22 hours with ≥80% of successful readings, and cumulative recording gaps no greater than 2 hours.
On the other hand, Hilo band blood pressure recordings are considered valid if at least 24 measurements are recorded per day/24-hours, for a total of at least 72 measurements recorded during the 3 days/72 hours period.
Measured: 3 days
Evaluate the performance of Hilo band in effectively classifying hypertension in young subjects of 14-35 years of age with the 24-h ABPM as a reference method.
We assess Hilo band's performance in classifying hypertensive and normotensive subjects as effective if Hilo band correctly classifies 90% of hypertensive subjects and 90% normotensive subjects, respectively. We define hypertensive and normotensive individuals as follows:
Hypertension for systolic and diastolic blood pressure measurement of Hilo band and 24-h ABPM:
- 24-h average: ≥ 130 mmHg and/or ≥80 mmHg
- Day time (or awake) average: ≥ 135 mmHg and/or ≥ 85 mmHg
- Night time (or sleep) average: ≥ 120 mmHg and/or ≥ 70 mmHg
Normotension for systolic and diastolic blood pressure measurement of Hilo band and 24-h ABPM:
- 24-h average: < 130 mmHg and/or < 80 mmHg
- Day time (or awake) average: < 135 mmHg and/or < 85 mmHg
- Night time (or sleep) average: < 120 mmHg and/or < 70 mmHg
Measured: 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.
The questionnaires we use to assess the degree of satisfaction with the use of Hilo band by the physicians and participants consist of two types of questions: questions with yes/no answers and questions with answers ranging from 1 (lowest satisfaction) to 5 (highest satisfaction). We define the degree of satisfaction with the use of Hilo band by the participants and physicians as follows:
- For questions with yes/no answers:
- 0-49% of total yes answers: participants and physicians not satisfied
- 50-69% of total yes answers: participants and physicians fairly satisfied
- 70-100% of total yes answers: participants and physicians very satisfied
- For questions with answers from 1 to 10:
- Average of answers < 2.75: participants and physicians not satisfied
- Average of answers between 2.75 and 3.75: participants and physicians fairly satisfied
- Average of answers > 3.75: participants and physicians very satisfied
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simonetti Giacomo
- Sponsor type
- University, hospital or other
- Collaborators
- SwissPedNet
- Responsible party
- Sponsor-investigator, Simonetti Giacomo, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Giacomo Simonetti, Prof. Dr. med, Principal investigator, Ente Ospedaliero cantonale (EOC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072689
- Sponsor's protocol ID
- IPSI-HYPE-001
- Acronym
- IPSI-HYPE-001
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07072689
- Acronym / sponsor ID
- IPSI-HYPE-001 / IPSI-HYPE-001
- Conditions
- Hypertension
- Keywords
- Aktiia, 24-h ABPM, hypertension, blood pressure, adolescents, Hilo, young population, EOC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Simonetti GiacomoUniversity, hospital or other
- Collaborators
- SwissPedNet
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Detailed description
This research project is a multi-center non-interventional performance study of San Giovanni Hospital in Bellinzona in collaboration with the Geneva University Hospitals (HUG) 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 14 and 35 years of age.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This is a multi-centre non-interventional performance research project investigating the performance of Hilo band in three different study populations: population 1, 2 and 3. In population 1, we will recruit young participants between 14 and 20 years of age that come to San Giovanni Hospital in Bellinzona or to HUG with indication to receive a 24-hour ABPM. In population 2, we will recruit young participants between 21 and 35 years of age that come to San Giovanni Hospital in Bellinzona or to HUG with indication to receive a 24-hour ABPM. In population 3, we will recruit healthy, voluntary individuals between 21 and 35 years of age.
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (15 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the 24-hour performance of Hilo band in measuring diastolic and systolic blood pressure values in young subjects of 14-35 years of age. We will use the 24h ABPM as a reference method
Time frame: 24 hours
To assess our primary endpoint, the 24-hour systolic and diastolic pressure averages (including waking and sleeping hours) of Hilo band will be compared to the 24-hour systolic and diastolic pressure averages of the 24-h ABPM, respectively. A similar performance of the two devices is defined as a standard deviation from the 24-hour (including waking and/or sleeping hours) average systolic and/or diastolic pressure values of maximum 10 mmHg, as reported in previous studies. We will consider valid and include in the analysis 24-h ABPM recordings lasting ≥22 hours with ≥80% of successful readings, and cumulative recording gaps no greater than 2 hours. On the other hand, Hilo band's blood pressure recordings are considered valid if at least 24 measurements are recorded during the 24 hours period.
3 secondary outcomes
Assessing the consistency of the performance of Hilo band in measuring systolic and diastolic blood pressure values in young subject of 14-35 years of age over a 3-day period with the 24-h ABPM as a reference method
Time frame: 3 days
Evaluate the performance of Hilo band in effectively classifying hypertension in young subjects of 14-35 years of age with the 24-h ABPM as a reference method.
Time frame: 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.
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giacomo Simonetti, Prof. Dr. med principal investigator
Ente Ospedaliero cantonale (EOC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Simonetti Giacomo at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Pedrotti, MSc (+41918119738, lisa.pedrotti@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the 24-hour performance of Hilo band in measuring diastolic and systolic blood pressure values in young subjects of 14-35 years of age. We will use the 24h ABPM as a reference method (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.