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Идёт набор NCT06368206

Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)

Без фазы С лечением 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: Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff, Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2, Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff.
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
Швейцария
Следующий шаг
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Официальное название

Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study

Обзор

The present study, OBPM\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.

Вмешательства

  • Устройство Investigational device Aktiia G2C
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
  • Устройство Marketed device used as reference for blood pressure monitoring: double auscultation cuff
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
  • Устройство Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
  • Устройство Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
    Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
  • Устройство Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
    Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
  • Устройство Marketed device used as reference for pulse rate monitoring: pulse finger oximeter
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.

Первичные конечные точки

  • Number of study subjects that contribute with analyzable raw data collected [Срок оценки: 1 hour]
Вторичные конечные точки (3)
  • Blood pressure mean value of differences [Срок оценки: 1 hour]
  • Blood pressure standard deviation of differences [Срок оценки: 1 hour]
  • Pulse rate root-mean-square error [Срок оценки: 1 hour]

Критерии участия

Критерии включения

  • Subjects aged 21 to 85yo
  • Subjects fluent in written and spoken French
  • Subjects agreeing to attend the study visit and follow study procedures
  • Subjects that have signed the informed consent form.

Критерии исключения

  • Amputated index fingers
  • Damaged/injured skin at index fingers
  • Damaged/injured skin at wrists
  • Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation
  • Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
  • Pregnant women
  • Polyneuropathy

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • CHUV — Lausanne

Публикации

  • Zahnd J, Thompson B, Rigon PA, Taffe P, Wuerzner G. Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision. Hypertens Res. 2026 Mar;49(3):969-973. doi: 10.1038/s41440-025-02514-3. Epub 2026 Jan 9. PMID 41514019

Идентификаторы

NCT: NCT06368206 · OBPM_Calfree2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗