Actively Recruiting
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
Led by Aktiia SA · Updated on 2024-08-19
225
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged between 21 and 85 years old
- Subjects who can read and speak French
- Subjects capable of performing simple physical exercises
- Subjects willing to attend all 9 study visits
- Subjects who have signed the informed consent form
You will not qualify if you...
- Clinical staff collaborating with the study principal investigator
- Subjects with resting tachycardia (heart rate over 120 bpm)
- Subjects diagnosed with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions
- Subjects with hyper- or hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects experiencing trembling or shivering
- Subjects with interarm systolic blood pressure difference greater than 15 mmHg
- Subjects with interarm diastolic blood pressure difference greater than 10 mmHg
- Subjects with arm paralysis
- Women known to be pregnant (for ARM 1 only)
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with upper arm circumference less than 22 cm or greater than 42 cm
- Subjects with wrist circumference greater than 21 cm
- Subjects with exfoliative skin diseases
- Subjects with lymphoedema
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Lausanne Hospitals
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
J
Josep Sola, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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