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

NCT05236348 | Recruiting

• 1 other identifier: OBPM_Auscultatory2022
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Blood Pressure; Heart Rate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Heart rate root-mean-square error

  1 week

Study Arms (2)

Patients 21-60yo with Aktiia.product-us

EXPERIMENTAL

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

Patients 60-85yo with Aktiia.product-us

EXPERIMENTAL

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

Interventions

Aktiia.product-us DEVICE

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.

Also known as: Aktiia bracelet, Aktiia product, Aktiia.product

Patients 21-60yo with Aktiia.product-us; Patients 60-85yo with Aktiia.product-us

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktiia SA: lead

Study Sites (1)

University of Lausanne Hospitals

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gregoire Wuerzner, MD

  Service of Nephrology and Hypertension CHUV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Sola, PhD

CONTACT

+41797689800; josep@aktiia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study participants will wear the Aktiia.bracelet-us during 9 visits that will be held over the span of seven days. 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 during these visits.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 11, 2022
• Study Start: January 11, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)