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) (OBPM_ABPM2020)

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Blood Pressure
• Intervention / Treatment: Device: Aktiia.product

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Neuchâtel, Switzerland, 2000
    • Réseau Hospitalier Neuchâtelois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cyril Pellaton
• Collaborators: Aktiia SA

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_ABPM2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No