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Recruiting NCT06368206

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)

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 21 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device Investigational device Aktiia G2C
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
  • Device Marketed device used as reference for blood pressure monitoring: double auscultation cuff
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
  • Device Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
  • Device Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
    Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
  • Device Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
    Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
  • Device Marketed device used as reference for pulse rate monitoring: pulse finger oximeter
    Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.

Primary outcome measures

  • Number of study subjects that contribute with analyzable raw data collected [Time frame: 1 hour]
Secondary outcome measures (3)
  • Blood pressure mean value of differences [Time frame: 1 hour]
  • Blood pressure standard deviation of differences [Time frame: 1 hour]
  • Pulse rate root-mean-square error [Time frame: 1 hour]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Amputated index fingers
  • Damaged/injured skin at index fingers
  • Damaged/injured skin at wrists
  • 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
  • Pregnant women
  • Polyneuropathy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 1 center
  • CHUV — Lausanne

Publications

  • Zahnd J, Thompson B, Rigon PA, Taffe P, Wuerzner G. Comparison of two validated oscillometric devices in a home-like setup reveals pronounced blood pressure differences and reduced precision. Hypertens Res. 2026 Mar;49(3):969-973. doi: 10.1038/s41440-025-02514-3. Epub 2026 Jan 9. PMID 41514019

Identifiers

NCT: NCT06368206 · OBPM_Calfree2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗