Blood Pressure, Hypertension
Conditions
Brief summary
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
Interventions
DEVICEAktiia.product
The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.
Sponsors
Aktiia SA
Cyril Pellaton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard deviation of the error for heart rate | up to 24 hours | The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm |
| Mean error for blood pressure | up to 24 hours | The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg |
| Standard deviation of the error for blood pressure | up to 24 hours | The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg |
| Mean absolute error for heart rate | up to 24 hours | The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm |
| Mean error for heart rate | up to 24 hours | The mean error between the Reference and Aktiia.product for heart rate in bpm |
| Mean absolute error for blood pressure | up to 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of patient's satisfaction for the two devices through a survey with multiple questions | up to 24 hours | 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. |
| Assessment of the calibration stability of Aktiia OBPM algorithms | 12 weeks | Use different calibration points going from 1 to 12 weeks |
| Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program | 12 weeks | comparison of blood pressure determinations taken at the beginning and at the end of the program in ambulatory settings |
| Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics. | 1 week | 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. |
Countries
Switzerland
Outcome results
None listed