Status:
RECRUITING
Photoplethysmographic Measurements of Pulse Wave Velocity (PWV) and Blood Pressure (BP)
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Commissariat A L'energie Atomique
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 th...
Detailed Description
The aim is to test on healthy volunteers a prototype of a non-invasive, non-CE marked medical device (VOP1k ) for the continuous monitoring of pulse wave velocity (PWV) and to study the relationship b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05393401
Start Date
October 25 2022
End Date
June 30 2026
Last Update
September 2 2025
Active Locations (1)
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1
Clinatec Cea/Chuga
Grenoble, France, 38054