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

NCT05236348 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2024-08-19

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Aktiia SA

    lead INDUSTRY

Principal Investigators

  • Gregoire Wuerzner, MD · Service of Nephrology and Hypertension CHUV

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236348 on ClinicalTrials.gov