Wearable Evaluation of Ambulatory Readings for Blood Pressure

Обзор

The purpose of this project is to compare the performance and validity of novel wearable technologies that measure blood pressure (BP) and physical activity with a Spacelabs Ambulatory Blood Pressure Monitoring (ABPM) device.

Подробное описание

The investigators will recruit community-dwelling participants to wear novel cuffless BP monitoring devices for comparison with a Spacelabs ABPM device throughout a 24-hour period. The identification of accurate cuffless BP technologies would greatly improve access to ABPM and allow for BP measurements at times when the use of cuff-based devices are not feasible. Knowledge from this project will inform subsequent research protocols among adults and under-represented groups.

Up to 250 participants (at least 100) will be involved in this study each wearing up to 7 devices (6 BP devices and 1 activity monitor). The assignment of devices will be randomized by day and by the arm or wrist on which they are worn. During the first visit, participants will provide their consent and be randomly fitted with 3 BP devices; either the Spacelabs ABPM device or the ABPMpro device, the Aktiia wristband BP monitor, and one of two other cuff-based wrist BP monitors, along with an activity monitor to track body positions. These devices will be worn continuously for at least 24-hours, including overnight, before being returned. On the following day, for Visit 2, participants will be fitted with a different set of 3 BP devices; the ABPMpro device or Spacelabs ABPM device, the Aktiia wristband BP device (on the opposite wrist from the previous day), and the final cuff-based wristband BP device. Additionally, participants will wear an ambulatory BP device as a patch on the chest. These devices will also be worn for at least 24 hours. This study will enable characterization of the feasibility, practicality, and effectiveness of the measurements and the devices\' accuracy and precision.

Вмешательства

• Устройство ABPMPro
  This is an upper arm, cuff-based intermittent ambulatory BP device. This device has an internal activity and body position sensor which gathers information about sleep-wake estimation.
• Устройство Spacelabs Ambulatory Blood Pressure Monitoring
  This is an upper arm cuff-based device with tubing for continuous ambulatory BP monitoring with a unique activity sensor that correlate with patient movement activity with blood pressure changes.
• Устройство Aktiia Blood Pressure
  This is a wrist cuff-based device which uses an optical sensor (photoplethysmography sensor) to gather data from the arteries under the skin surface. Aktiia has an upper arm cuff device which is used for calibration once every month to provide a baseline blood pressure reading.
• Устройство LiveMetric
  This is a wrist cuff-based applanation tonometry continuous ambulatory BP device. This device has automatic self-calibration and comes in various sizes.
• Устройство Bpro
  This is a wrist cuff-based wireless oscillometric, continuous ambulatory BP device. It has applanation tonometry at the wrist with Pulse wave analysis. This device needs calibration with a brachial cuff BP measurement.

Первичные конечные точки

• Systolic Blood Pressure [Срок оценки: 24 - 48 hours]

Вторичные конечные точки (3)

• Diastolic Blood Pressure [Срок оценки: 24 - 48 hours]
• Heart Rate [Срок оценки: 24 - 48 hours]
• ActivPaL device (Physical activity monitor) [Срок оценки: 24 - 48 hours]

Критерии участия

Критерии включения

• Age 18 to 100 years
• All neighborhoods in Boston area
• Be able to walk with two limbs and have two arms
• Willing and able to complete required measurement procedures
• Able to provide informed consent

Критерии исключения

• Failure to receive informed consent
• Arm circumference of more than 50cm

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Beth Israel Deaconess Medical Center — Boston

Идентификаторы

NCT: NCT06610448 · 2024P000441 · 5R01HL158622

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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