Status:
RECRUITING
Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
Lead Sponsor:
Aktiia SA
Conditions:
Hypertension
Blood Pressure
Eligibility:
All Genders
21-85 years
Phase:
NA
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05236348
Start Date
January 11 2022
End Date
March 31 2025
Last Update
August 19 2024
Active Locations (1)
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1
University of Lausanne Hospitals
Lausanne, Switzerland, 1011