Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

Официальное название

Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation

Обзор

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

Подробное описание

According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population is not diagnosed, and half of the treated population is not at the defined target of BP. Widespread use of out of office BP measurement is one of the proposed strategies to fight against hypertension worldwide.

The current Ambulatory Blood Pressure Monitoring or Home Blood Pressure Monitoring are performed with a cuff placed around the arm. This 110-year-old technology is not only uncomfortable for the patient but can also result in a number of overestimated readings due to the stress induced while inflating the cuff.

Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor determining over a series of cardiac cycles the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist. The optical sensors integrated within the device exploit the principle of reflection photoplethysmography (PPG) to capture the user's skin pulsatility (change of arterial diameter occurring at each heartbeat). Aktiia OBPM algorithms are further applied to the recorded PPG signal to determine user's blood pressure and heart rate.

Because the measurement relies on optical sensors, and not on pneumatic cuffs, Aktiia OBPM device provides an increased overall comfort to the patient throughout the monitoring, does not induce sleep arousal during the night measurements and decreases the false positive readings induced by the stress associated with the cuff inflation. Aktiia OBPM device is intended to be used in the long term, as compared to one-day or one-week use of Ambulatory Blood Pressure Monitors.

This study over several visits has been designed to assess both the accuracy and the stability of the Aktiia OBPM. The automaticity of the measurement when performed in different body positions and upon aerobic exercise was also evaluated.

By demonstrating both the accuracy and the stability of the measurements that can be performed in different body positions with a comfortable and miniature Aktiia OBPM device, Aktiia SA aims to make one step further in facilitating blood pressure measurement and monitoring in the out-of-clinic scenarios and integrating blood pressure monitoring into user's daily life. The diagnosis and treatment of hypertension in ambulatory settings is expected to largely benefit from these advancements

Вмешательства

• Устройство Aktiia.product-P0
  The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.

Первичные конечные точки

• Blood Pressure absolute Mean Error [Срок оценки: Up to four weeks]
• Blood Pressure standard Deviation of the Error [Срок оценки: Up to four weeks]

Вторичные конечные точки (1)

• Heart Rate root-mean-square error [Срок оценки: Up to four weeks]

Критерии участия

ARM1

Критерии включения

• Adult subjects (aged between 21 and 65 years old)
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects that have signed the informed consent form

Критерии исключения

• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
• Subjects with hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
• Subjects with lymphoedema (limitation due to participant discomfort)

ARM2

Критерии включения

• Adult subjects (aged between 21 and 65 years old)
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects that have signed the informed consent form

Критерии исключения

• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
• Subjects with lymphoedema (limitation due to participant discomfort)

ARM3

Критерии включения

• Adult subjects (aged between 65 and 85 years old)
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects that have signed the informed consent form

Критерии исключения

• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
• Subjects with hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
• Subjects with lymphoedema (limitation due to participant discomfort)

ARM 4

The study arm will include:

• Adult subjects aged between 21 and 85 years old
• Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects residing within 100 km of the CHUV site
• Subjects able to pedal with an ergocycle
• Subjects that have signed the informed consent form

The study will exclude:

• Subjects undergoing dialysis treatment
• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with untreated hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 23 cm
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases
• Subjects with lymphoedema

ARM 5

The study arm will include:

• Adult subjects aged between 21 and 85 years old
• Subjects with chronic systolic heart failure (Heart Failure with reduce Ejection Fraction), defined by a left ventricular ejection fraction (LVEF) of less than or equal to 40%, confirmed by Echocardiography or MRI
• Subjects fluent in written and spoken French

Subjects agreeing to attend the totality of 4 visits

• Subjects residing within 100 km of the CHUV site
• Subjects able to pedal with an ergocycle
• Subjects that have signed the informed consent form

The study will exclude:

• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
• Subjects with untreated hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 23 cm
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases
• Subjects with lymphoedema

ARM 6

The study arm will include:

• Subjects who are adult females aged 21 years or older
• Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist
• Subjects not requiring hospitalization
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects residing within 100 km of the CHUV site.
• Subjects that have signed the informed consent form

The study will exclude:

• Subjects with tachycardia (heart rate at rest > 120bpm
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
• Subjects with untreated hyper/hypotyroidism not related to pregnancy changes
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 23 cm
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases
• Subjects with lymphoedema

ARM 7

The study arm will include:

• Subjects who are adult females aged 21 years or older
• Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant
• Subjects fluent in written and spoken French
• Subjects agreeing to attend the totality of 4 visits
• Subjects residing within 100 km of the CHUV site.
• Subjects that have signed the informed consent form

The study will exclude:

• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
• Subjects with untreated hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with trembling and shivering
• Subjects with interarm systolic difference > 15 mmHg
• Subjects with interarm diastolic difference > 10 mmHg
• Subjects with arm paralysis
• Women in known pregnancy
• Subjects with an arteriovenous fistula
• Subjects with arm amputations Subjects with the upper arm circumference > 64 cm
• Subjects with the wrist circumference > 23 cm
• Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
• Subjects with the exfoliative skin diseases
• Subjects with lymphoedema.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Швейцария · 1 центр

• University of Lausanne Hospitals — Lausanne

Публикации

• Theiler K, Sola J, Damianaki A, Pfister A, Almeida TP, Alexandre J, Vermare P, Wuerzner G. Performance of the Aktiia optical blood pressure measurement device in the elderly: a comparison with double blinded auscultation in different body positions. Blood Press. 2023 Dec;32(1):2281320. doi: 10.1080/08037051.2023.2281320. Epub 2023 Nov 16. PMID 37971487

Идентификаторы

NCT: NCT04027777 · OBPM_Ambulatory2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗