Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation

Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation

This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Blood Pressure; Heart Rate
• Intervention / Treatment: Device: Aktiia.product-us

Detailed Description

According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population suffering from hypertension is currently not diagnosed and half of the treated population is not at the defined target of BP.

Widespread use of out-of-office Blood Pressure measurement is one of the proposed strategies to fight against hypertension worldwide.

Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor, determining the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist.

The goal of this study is to establish a reasonable assurance of safety and effectiveness with Aktiia OBPM system for monitoring blood pressure in home use.

In particular, the study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce Blood Pressure changes, during eight visits that will be held over the span of seven days, and generate performance reports.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep Sola, PhD; Phone Number: +41797689800; Email: josep@aktiia.com

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • University of Lausanne Hospitals
    • Contact: Grégoire Wuerzner, MD; Phone Number: +41213141131; Email: gregoire.wuerzner@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult subjects (aged between 21 and 85 years old)
• Subjects can read and speak French
• Subjects can perform simple physical exercises
• Subjects agreeing to attend the totality of 9 visits
• Subjects that have signed the informed consent form

Exclusion Criteria:

• Clinical staff collaborating with study PI
• Subjects with tachycardia (heart rate at rest > 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with renal dysfunctions
• Subjects with hyper-/hypothyroidism
• 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 (for ARM 1 only)
• Subjects with an arteriovenous fistula
• Subjects with arm amputations
• Subjects with the upper arm circumference < 22cm or > 42 cm
• Subjects with the wrist circumference > 21 cm
• Subjects with the exfoliative skin diseases
• Subjects with lymphoedema

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients 21-60yo with Aktiia.product-us; All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days.	Device: Aktiia.product-us; The study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce BP changes, during eight visits that will be held over the span of seven days, and generate performance reports.; Other Names: Aktiia bracelet; Aktiia product; Aktiia.product
Experimental: Patients 60-85yo with Aktiia.product-us; All study participants will wear the Aktiia.product-us during 9 visits that will be held over the span of seven days.	Device: Aktiia.product-us; The study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce BP changes, during eight visits that will be held over the span of seven days, and generate performance reports.; Other Names: Aktiia bracelet; Aktiia product; Aktiia.product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure mean value of differences	The mean value of the differences between Aktiia.product-us and double auscultation blood pressure measurements.	1 week
Blood pressure standard deviation of differences	The standard deviation of the differences between Aktiia.product-us and double auscultation blood pressure measurements.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate root-mean-square error	The root-mean-square difference between the Aktiia.product-us heart rate determinations and the reference method.	1 week

Collaborators and Investigators

• Sponsor: Aktiia SA
• Investigators: Principal Investigator: Gregoire Wuerzner, MD, Service of Nephrology and Hypertension CHUV

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_Auscultatory2022

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