Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

Aktiia

Status: Enrolling

Conditions: Blood Pressure

Treatments: Device: Aktiia.product-P0

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04027777

OBPM_Ambulatory2019

Details and patient eligibility

About

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

Full description

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

Enrollment: 355 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

ARM1

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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355 participants in 7 patient groups

Aktiia.product-P0

Experimental group

Description:

Main study arm including 105 subjects

Treatment:

Device: Aktiia.product-P0

Aktiia.product-P0 Diabetics

Experimental group

Description:

Second study arm including 40 diabetic patients

Treatment:

Device: Aktiia.product-P0

Aktiia.product-P0 Aged

Experimental group

Description:

Thirs study arm including 40 patients aged 65+

Treatment:

Device: Aktiia.product-P0

Aktiia.product-P0 and subjects with Chronic Kidney disease

Experimental group

Description:

Additional study arm including 40 subjects with chronic kidney disease (ARM 4)

Treatment:

Device: Aktiia.product-P0

Aktiia.product-P0 and subjects with Heart Failure

Experimental group

Description:

Additional study arm including 40 subjects with Heart Failure (ARM 5)

Treatment:

Device: Aktiia.product-P0

Aktiia.product-P0 and Pregnant subjects

Experimental group

Description:

Additional study arm including 50 pregnant subjects (ARM 6)

Treatment:

Device: Aktiia.product-P0

Aktiia.product-P0 and subjects in Post partum

Experimental group

Description:

Additional study arm including 40 subjects in post partum (ARM 7)

Treatment:

Device: Aktiia.product-P0