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

NCT05393401 | Recruiting

• 1 other identifier: 38RC21.0460
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Volunteers

Keywords

Photoplethysmography; Pulse Wave Velocity (PWV); Blood Pressure (BP)

Outcome Measures

Primary Outcomes (1)

• 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.

  Measurement of the degree of correlation between the PWV estimated from the device under study and the PWV measured by the "Complior®" reference device. "

  4 hours

Secondary Outcomes (5)

• Determination of the most adequate distance between the sensors for measuring PWV

  4 hours

• Study of the relationship between the PWV measured with the device and BP measurement obtained with the gold standard (discrete auscultatory measurements and continuous Clearsight measurements)

  4 hours

• Determination of the most adequate algorithm to obtain BP values from PWV

  4 hours

• Check that the signal processing makes it possible to adapt to physiological variations in BP in the same individual

  4 hours

• Check that the signal processing to obtain the BP can be adapted to different individuals

  4 hours

Study Arms (1)

VOP1k

EXPERIMENTAL

Medical Device

Device: VOP1k

Interventions

VOP1k DEVICE

Photoplethysmographic records

VOP1k

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 who would receive more than 4500 euros in compensation due to his participation in other biomedical research in the 12 months preceding this study

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator

Study Sites (1)

Clinatec Cea/Chuga

Grenoble, 38054, France

RECRUITING

Related Publications (5)

• Sharman JE, O'Brien E, Alpert B, Schutte AE, Delles C, Hecht Olsen M, Asmar R, Atkins N, Barbosa E, Calhoun D, Campbell NRC, Chalmers J, Benjamin I, Jennings G, Laurent S, Boutouyrie P, Lopez-Jaramillo P, McManus RJ, Mihailidou AS, Ordunez P, Padwal R, Palatini P, Parati G, Poulter N, Rakotz MK, Rosendorff C, Saladini F, Scuteri A, Sebba Barroso W, Cho MC, Sung KC, Townsend RR, Wang JG, Willum Hansen T, Wozniak G, Stergiou G; Lancet Commission on Hypertension Group. Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure. J Hypertens. 2020 Jan;38(1):21-29. doi: 10.1097/HJH.0000000000002246.

  PMID: 31790375 BACKGROUND

• Vlachopoulos C, Aznaouridis K, O'Rourke MF, Safar ME, Baou K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with central haemodynamics: a systematic review and meta-analysis. Eur Heart J. 2010 Aug;31(15):1865-71. doi: 10.1093/eurheartj/ehq024. Epub 2010 Mar 2.

  PMID: 20197424 BACKGROUND

• Bramwell C, Hill and AV, The Velocity of the Pulse Wave in Man, Proc. R. Soc. Lond. B 1922 93, 298-306

  BACKGROUND

• Lubin M, Vray D, Bonnet S. Blood pressure measurement by coupling an external pressure and photo-plethysmographic signals. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:4996-4999. doi: 10.1109/EMBC44109.2020.9176730.

  PMID: 33019108 BACKGROUND

• Block RC, Yavarimanesh M, Natarajan K, Carek A, Mousavi A, Chandrasekhar A, Kim CS, Zhu J, Schifitto G, Mestha LK, Inan OT, Hahn JO, Mukkamala R. Conventional pulse transit times as markers of blood pressure changes in humans. Sci Rep. 2020 Oct 2;10(1):16373. doi: 10.1038/s41598-020-73143-8.

  PMID: 33009445 BACKGROUND

Central Study Contacts

Daniel ANGLADE, MD, PhD

CONTACT

04 38 78 17 46; danglade@chu-grenoble.fr

Caroline SANDRE-BALLESTER, PhD

CONTACT

04 38 78 28 51; csandreballester@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The Primary Purpose of this clinical trial is to test a prototype device for feasibility and not health outcomes. This study is conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. Primary Purpose is therefore "Device Feasibility"

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: October 25, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)