Actively Recruiting

Phase Not Applicable
Age: 21Years - 85Years
All Genders
Healthy Volunteers
NCT04027777

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

Led by Aktiia SA · Updated on 2026-04-06

355

Participants Needed

1

Research Sites

438 weeks

Total Duration

On this page

Sponsors

A

Aktiia SA

Lead Sponsor

U

University of Lausanne Hospitals

Collaborating Sponsor

AI-Summary

What this Trial Is About

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

CONDITIONS

Official Title

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

Who Can Participate

Age: 21Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult subjects aged between 21 and 65 years old
  • Subjects fluent in written and spoken French
  • Subjects agreeing to attend all 4 visits
  • Subjects who have signed the informed consent form
Not Eligible

You will not qualify if you...

  • Resting heart rate greater than 120 beats per minute
  • History of atrial fibrillation
  • Diagnosis of diabetes
  • Renal dysfunction with eGFR less than 60 mL/min/1.73 m2
  • Hyperthyroidism or hypothyroidism
  • Pheochromocytoma
  • Raynaud's disease
  • Trembling or shivering
  • Interarm systolic difference greater than 15 mmHg
  • Interarm diastolic difference greater than 10 mmHg
  • Arm paralysis
  • Known pregnancy
  • Presence of an arteriovenous fistula
  • Arm amputations
  • Upper arm circumference greater than 64 cm
  • Wrist circumference greater than 22 cm
  • Central phalanx of middle finger circumference greater than 71 mm or less than 43 mm
  • Exfoliative skin diseases
  • Lymphoedema

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Lausanne Hospitals

Lausanne, Switzerland, 1011

Actively Recruiting

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Research Team

J

Josep Sola, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

7

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