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Recruiting Not applicable

Photoplethysmographic Measurements of Pulse Wave Velocity (PWV) and Blood Pressure (BP)

NCT05393401 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-10-25
Last updated
2025-09-02

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

VOP1k

VOP1k: Photoplethysmographic records

Study summary

Theoretically, there is a correlation between the PWV and the value of the BP, mediated by the distensibility of the segment of artery where the measurements take place. The hypothesis is therefore that the measurement of the PWV through a multisite medical device for detecting the pulse wave by photoplethysmography makes it possible to deduce the value of the BP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy healthy volunteer subject, * Aged 18 or over, * Having expressed their consent to the research, * Affiliated to a social security scheme, * Registered in the national file of people who lend themselves to biomedical research Exclusion Criteria: * People referred to in Articles L1121-5 to L1121-8 of the Public Health Code (corresponds to all protected persons: pregnant, parturient or breastfeeding women, persons deprived of liberty by judicial or administrative decision, persons subject of psychiatric care, minor, and person subject to a legal protection measure: guardianship, curatorship or safeguard of justice) * Any history or presence of chronic illness * Presence of Wolf Parkinson White ECG changes * Subject with orthostatic hypotension * People with an active implant (e.g. pacemaker) * Known allergy or intolerance to silicone * Orthostatic hypotension * Cutaneous excoriations preventing the placement of sensors on the arms * Patient with an active implant * Subject cannot be contacted in case of emergency * Taking treatment that may impact the recorded physiological measurements * Subject in period of exclusion from another clinical investigation * Subject who would receive more than 4500 euros in compensation due to his participation in other biomedical research in the 12 months preceding this study

Primary outcome measure(s)

  • Collect and process the pulse wave signal by the multi-site photoplethysmographic method in order to assess the feasibility and reliability of PWV measurement by this technique in a healthy adult population. — 4 hours
    Measurement of the degree of correlation between the PWV estimated from the device under study and the PWV measured by the "Complior®" reference device. "

Trial sites (1)

FacilityCityRegionStatus
Clinatec Cea/Chuga Grenoble France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05393401 on ClinicalTrials.gov ↗ ← All trials in France