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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Population 2
No indications for blood pressure measurements
Population 1
Indications to receive blood pressure measurement of 24-hours
结局指标
主要结局
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
时间窗: 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.
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
时间窗: 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.
次要结局
- 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(3 days)
- 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.(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.(3 days)
- 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(3 days)
- 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.(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.(3 days)
研究者
Simonetti Giacomo
Prof. Dr. med
Ente Ospedaliero Cantonale, Bellinzona