Testing a fingertip optical sensor for blood pressure in adults with hypertension
Compares a fingertip optical blood pressure device with reference devices in people with hypertension.
Key facts
- Who runs it
- Aktiia SA
- Where
- Lausanne, SwitzerlandSee the site
- Trial code
- Registry title
- Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
- Status
- Recruiting
- People taking part
- 85 people, planned
- Started
- 25 Jun 2024
- Planned end
- 31 Dec 2025
- Type of study
- Interventional
- Treatments tested
- Investigational device Aktiia G2C
- Marketed device used as reference for blood pressure monitoring: double auscultation cuff
- Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
- Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
- Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
- Marketed device used as reference for pulse rate monitoring: pulse finger oximeter
- Record updated
- 17 December 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 21 to 85 who speak French and will attend one study visit of about 1 hour. Blood pressure is measured with a fingertip optical sensor and reference devices.
- Age
- 21 to 85 years
- Sex
- All sexes can join.
Main reasons for not taking part
- Amputated index finger, or damaged or injured skin on the index fingers or wrists
- Long-lasting heart rhythm problems such as atrial fibrillation or a resting heart rate above 120bpm
- Conditions that reduce blood flow in the limbs, such as Raynaud's disease, diabetes, kidney problems (eGFR < 30mL/min/1.73 m2), thyroid disease, pheochromocytoma or arteriovenous fistula
- Pregnant women
- Polyneuropathy
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Subjects aged 21 to 85yo
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the study visit and follow study procedures
- Subjects that have signed the informed consent form
Who cannot take part
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation
- Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
- Amputated index fingers
- Damaged/injured skin at index fingers
- Damaged/injured skin at wrists
- Pregnant women
- Polyneuropathy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 85 years old?
Where in Switzerland
- CHUVLausanne, SwitzerlandContact: Grégoire Wuerzner, MD ProfTaking people
About the trial
What the trial wants to find out
The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
The group in the trial
- Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoringOther group
All study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter).
Treatment: Investigational device Aktiia G2C, Marketed device used as reference for blood pressure monitoring: double auscultation cuff, Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2, Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff, Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff, and Marketed device used as reference for pulse rate monitoring: pulse finger oximeter
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
- Plain-language title
- Testing a fingertip optical sensor for blood pressure in adults with hypertensionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06368206, who can take part
- Publications
- Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision.Hypertension research : official journal of the Japanese Society of Hypertension, 2026
- Record updated
- 17 December 2024