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)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cyril Pellaton
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Mean error for blood pressure
Overview
Brief Summary
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Mean error for blood pressure
Time Frame: up to 24 hours
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
Mean absolute error for blood pressure
Time Frame: 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
Standard deviation of the error for blood pressure
Time Frame: 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
Time Frame: 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
Time Frame: up to 24 hours
The mean error between the Reference and Aktiia.product for heart rate in bpm
Standard deviation of the error for heart rate
Time Frame: up to 24 hours
The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm
Secondary Outcomes
- Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program(12 weeks)
- Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.(1 week)
- Evaluation of patient's satisfaction for the two devices through a survey with multiple questions(up to 24 hours)
- Assessment of the calibration stability of Aktiia OBPM algorithms(12 weeks)
Investigators
Cyril Pellaton
Cyril Pellaton
Hopital Neuchatelois