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Набор скоро начнётся NCT07099716

OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor

— Наблюдательное Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor.
Кому может быть актуально
Состояния в реестре: Hypertension. Базовые параметры: 21 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor: a Single-center, Prospective Clinical Study.

Обзор

The OBPM\_HARMONY study will enroll a minimum of 300 participants at the CHUV site in Lausanne, Switzerland. Each participant will complete two study visits at CHUV, scheduled at least 24.5 hours apart. Between these visits, participants will be asked to wear both the Hilo band, an Ambulatory Blood Pressure Monitor (ABPM) as well as a hydrostatic pressure system continuously for a 24-hour period.

Подробное описание

The OBPM\_HARMONY study will enroll a minimum of N= 300 participants. Each participant will complete two visits at the CHUV site in Lausanne, Switzerland: Visit 1 (\~40 minutes) and Visit 2 (\~15 minutes), spaced at least 24.5 hours apart. During Visit 1, participants are equipped with three devices- the Device Under Test (Hilo band), the reference device (Ambulatory Blood Pressure Monitor), worn on the opposite arm, and a hydrostatic pressure system on the chest. Subjects are instructed to wear the three devices for the next 24 hours to collect blood pressure (BP) and heart rate (HR) data, as well as hydrostatic pressure measurements. After Visit 1, subjects return home with the devices in place. Visit 2 takes place at least 24.5 hours later, when participants return to the site to hand back the equipment and complete a feedback survey regarding their experience using the Hilo band and the ABPM reference.

Вмешательства

  • Устройство Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor
    During study Visit 1, participants are equipped with tthree devices- the Device Under Test (Hilo band), the reference device (Ambulatory Blood Pressure Monitor), worn on the opposite arm, and a Hydrostatic pressure monitor on the chest. Subjects are instructed to wear the three devices for the next 24 hours to collect blood pressure (BP) and heart rate (HR) data as well as hydrostatic pressure measurements. After Visit 1, subjects return home with the devices in place. Visit 2 takes place at lea

Первичные конечные точки

  • Raw 24-hour data collection using the continual Hilo monitor alongside the Ambulatory Blood Pressure Monitor across minimum 300 study subjects. [Срок оценки: 24 hours]
Вторичные конечные точки (1)
  • Evaluation of survey results on comfort, usability, and ease of use for both devices [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • Subjects aged 21 to 85yo
  • Subjects fluent in written and spoken French, capable of discernment
  • Subjects agreeing to attend the two study visits and follow study procedures
  • Subjects residing within 100 km of the CHUV site
  • Subjects that have signed the informed consent form.

Критерии исключения

  • Damaged/injured skin at the right wrist
  • Subjects with tachycardia (heart rate at rest > 120bpm)
  • Subjects with atrial fibrillation
  • Subjects with diabetes
  • Subjects with marked renal dysfunctions
  • Subjects with untreated hyper-/hypothyroidism
  • Subjects with pheochromocytoma
  • Subjects with Raynaud's disease
  • Subjects with an arteriovenous fistula
  • Subjects with implanted electrical devices, such as cardiac pacemakers or defibrillators
  • Subjects with premature ventricular beats
  • Subjects with peripheral arterial disease
  • Subjects undergoing intravascular therapy or arterio-venous shunt
  • Subjects who have received a mastectomy
  • Women in known pregnancy or women with pre-eclampsia
  • Subjects of unsound mind
  • Subjects with upper arm circumference < 22cm or > 42cm
  • Subjects with wrist circumference <14cm or > 23cm
  • A lateral difference in systolic blood pressure >15 mmHg or diastolic blood pressure >10 mmHg between arms.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07099716 · OBPM_HARMONY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗