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RecruitingNCT05393401MEPPAVOPUpdated Sep 2, 2025

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

An interventional study of VOP1k in Healthy Volunteers, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the 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 between this value and the blood pressure (BP). Indeed, the monitoring of hemodynamic parameters constitutes an essential element of the basal monitoring of patients. Among these parameters, the most used and the most routine is the measurement of BP. This measurement makes it possible in particular to detect the presence or absence of arterial hypertension (HTA), which is a major cause of premature mortality, of high prevalence within the population, involving high medical costs. Contrary to what one might think, the practice of measuring BP is not completely satisfactory, each of the techniques used having characteristics likely to lead to errors of judgment. Oscillometric and auscultatory techniques give discontinuous measurements, expose to the white coat effect when they are performed by a caregiver. Arterial occlusion by external back pressure, which is the basis of these measurement techniques, causes erroneous results and discomfort during repetitive measurements. The use of commercial semi-automatic BP monitors is fraught with validation problems. The necessary confirmation of the diagnosis of hypertension, which is based on ambulatory measurements for 24 hours using these devices, is therefore questionable. The diagnosis of the importance of arterial damage at the base of hypertension could be carried by measurements of the PWV which reflects the stiffness of the arteries. However, this diagnostic means is not currently based on a technology that can be used routinely. Means of measuring BP and arterial stiffness by invasive techniques, which are themselves subject to the risk of poor signal transmission, cannot be used outside the hospital, due to the associated risks. Non-invasive continuous measurement by the volume clamp technique, although devoid of the risks of arterial catheterization, is not available outside specialized hospital departments, and also has the disadvantage of relying on the use of external counter pressure.The technique of measurement by (photoplethysmography (PPG)), i.e. the use of an optical sensor, placed in a non-invasive way on the path of a shallow artery, makes it possible to detect the passage of the pulse wave . The combined use of several sensors located at a distance from each other on the path of the same artery, thus makes it possible to determine the velocity of the pulse wave. This technique can potentially measure over short distances, which limits the sources of error, and allows continuous measurement without discomfort. Moreover, it is compatible with low-cost integration. Indeed, acquisition technologies based on microelectronics are widely developed and mature since their massive use in smartphones. The measurement of PWV makes it possible to quantify arterial stiffness, which is a direct risk factor for morbidity and mortality associated with cardiovascular pathologies. The additional interest of this measurement, in addition to the fact of its non-invasiveness, comes from the fact that there is a correlation between the PWV and the BP, and therefore that the measurement of the PWV can make it possible to obtain a measurement of the BP. It should be noted that one aspect of the aspects of blood pressure measurement consists of being able to measure the central blood pressure, that is to say that which reigns in the aorta. However, most of the measurement techniques used routinely only measure the peripheral arterial pressure, which makes it necessary to use transfer functions to know the central pressure, or to ignore the differences in central pressure/peripheral pressure behavior. The technology proposed for the measurement makes it possible to consider overcoming this problem by placing, in one of the versions, a sensor at the carotid level, which is the arterial segment that best reflects the central pressure, unlike the humeral, femoral or radial segments.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Photoplethysmography
  • Pulse Wave Velocity (PWV)
  • Blood Pressure (BP)
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    VOP1k

    Medical Device

    Device: VOP1k

Interventions

  • DeviceVOP1k

    Photoplethysmographic records

06

What researchers measure

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. "

    Time frame: 4 hours

Secondary outcomes

  1. Determination of the most adequate distance between the sensors for measuring PWV

    Measurement of the standard PWV deviation measured by the Clearsight device, PWV estimated by the multi-site medical device VOP1k

    Time frame: 4 hours

  2. 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)

    Measurement of the difference between calculated BP and measured brachial BP to check that it does not exceed 5 to 8 mm Hg

    Time frame: 4 hours

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

    Calculation of the algorithm to minimize the difference between calculated BP and measured BP

    Time frame: 4 hours

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

    Calculation of the algorithm to minimize the difference between calculated BP and measured BP obtained during PA modifications caused by the different experimental conditions

    Time frame: 4 hours

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

    Calculation of the algorithm to minimize the difference between calculated BP and measured BP

    Time frame: 4 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 31790375 ↗
  • 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. PubMed 20197424 ↗
  • Bramwell C, Hill and AV, The Velocity of the Pulse Wave in Man, Proc. R. Soc. Lond. B 1922 93, 298-306
  • 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. PubMed 33019108 ↗
  • 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. PubMed 33009445 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05393401
Lead sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique
Responsible party
Sponsor
First posted
May 26, 2022
Start date
Oct 25, 2022
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 2, 2025

Study contacts

Daniel ANGLADE, MD, PhD
Contact
danglade@chu-grenoble.fr
04 38 78 17 46
Caroline SANDRE-BALLESTER, PhD
Contact
csandreballester@chu-grenoble.fr
04 38 78 28 51

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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