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

Cyril Pellaton63 enrolled

Overview

This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Blood Pressure Hypertension

Interventions

Aktiia.productDEVICE

The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult subjects (aged between 21 and 65) * Subjects fluent in written and spoken French * Subjects enrolled in a 12-weeks cardiac rehabilitation program * Subjects agreeing to participate * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with severe heart failure (LVEF\<35%) * Subjects with severe renal dysfunctions (eGFR \< 30mL/min/1.73 m2) * 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 * Subjects with the exfoliative skin diseases * Subjects with lymphoedema

Locations (1)

Réseau Hospitalier Neuchâtelois

Neuchâtel, Switzerland

Outcomes

Primary Outcomes

Mean absolute error for blood pressure

The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for systolic (SYS) and diastolic (DIA) blood pressure in mmHg

Time frame: up to 24 hours

Mean error for blood pressure

The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg

Time frame: up to 24 hours

Standard deviation of the error for blood pressure

The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg

Time frame: up to 24 hours

Mean absolute error for heart rate

The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm

Time frame: up to 24 hours

Mean error for heart rate

The mean error between the Reference and Aktiia.product for heart rate in bpm

Time frame: up to 24 hours

Standard deviation of the error for heart rate

The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm

Time frame: up to 24 hours

Secondary Outcomes

Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.

Aktiia values acquired during the first day (with ABPM) will be compared to values acquired during other days of the week and a t-test will be performed. The analysis will be repeated for night values.

Data from ClinicalTrials.gov

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