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

Phase

N/A

Condition

Stress

Vascular Diseases

Circulation Disorders

Treatment

Aktiia.product-us

Clinical Study ID

NCT05236348

OBPM_Auscultatory2022

Ages 21-85
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Aktiia.product-us

January 11, 2022

March 31, 2025

Study 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.

Connect with a study center

University of Lausanne Hospitals
Lausanne, 1011
Switzerland
Active - Recruiting

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