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)

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

Official Title
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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)

Conditions
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Blood Pressure, Hypertension

Intervention / Treatment
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* Device: Aktiia.product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br>single arm study | Device: Aktiia.product<br>* The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 24 hours | 
| Mean error for blood pressure | The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg | 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 | 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 | up to 24 hours | 
| Mean error for heart rate | The mean error between the Reference and Aktiia.product for heart rate in bpm | 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 | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 
| Evaluation of patient's satisfaction for the two devices through a survey with multiple questions | 10-points likert scale survey, an agree-disagree scale with minimum 0 and maximum 10. Minimum value means strong disagreement, maximum value means strong agreement. | up to 24 hours | 
| Assessment of the calibration stability of Aktiia OBPM algorithms | Use different calibration points going from 1 to 12 weeks | 12 weeks | 
| Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program | comparison of blood pressure determinations taken at the beginning and at the end of the program in ambulatory settings | 12 weeks |