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NCT Number: NCT07072689

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)

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    Time frame: 3 days

    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.

  2. 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.

    Time frame: 3 days

    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

  3. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Giacomo Simonetti

CONTACT

[email protected]

0918119804

Lisa Pedrotti, MSc

CONTACT

[email protected]

+41918119738

Sponsors and collaborators

Lead sponsor

Simonetti Giacomo

Other

Registry information

Acronym: IPSI-HYPE-001

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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