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.
Plain-language title generated from the registry record
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)
Key facts
- Where
- Lausanne, SwitzerlandSee the site
Could this be for you?
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?
Source: NCT06368206, who can take part
Where in Switzerland
- CHUVLausanne, SwitzerlandTaking people
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?
Trial details
- Who runs it
- Aktiia SA
- Trial code
- NCT06368206
- Record updated
- 17 December 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.