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)

Not Applicable

Completed

• Conditions: Blood Pressure; Hypertension
• Interventions: Device: Aktiia.product

• Registration Number: NCT04548986
• Lead Sponsor: Cyril Pellaton

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-06
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-16
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Aktiia.product	single arm study

Primary Outcome Measures

Name	Time	Method
Mean error for blood pressure	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	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	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
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

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Réseau Hospitalier Neuchâtelois; 🇨🇭 Neuchâtel, Switzerland