Healthy VolunteersMEPPAVOPNCT05393401
Photoplethysmographic Measurements of Pulse Wave Velocity (PWV) and Blood Pressure (BP)
A study testing VOP1k in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VOP1k
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinatec Cea/Chuga
Grenoble, 38054
Daniel ANGLADE, MD, PhD, 04 38 78 17 46, danglade@chu-grenoble.fr
Caroline SANDRE-BALLESTER, PhD, 04 38 78 28 51, csandreballester@chu-grenoble.fr
About this study
Official title: Photoplethysmographic Measurements of Pulse Wave Velocity (PWV) and Blood Pressure (BP) MEPPAVOP
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.
- Conditions
- Healthy Volunteers
- Being tested
- VOP1k
- Keywords
- Photoplethysmography, Pulse Wave Velocity (PWV), Blood Pressure (BP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOP1kDevice
Photoplethysmographic records
| Study group | Role | What they receive |
|---|---|---|
| VOP1k | Experimental | Medical Device Receives: Device: VOP1k |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. "
Measured: 4 hours
Secondary outcomes (5)
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
Measured: 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)
Measurement of the difference between calculated BP and measured brachial BP to check that it does not exceed 5 to 8 mm Hg
Measured: 4 hours
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
Measured: 4 hours
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
Measured: 4 hours
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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 Oct 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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"
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393401
- Sponsor's protocol ID
- 38RC21.0460
- Acronym
- MEPPAVOP
- Status last verified
- Aug 2025
- First submitted
- 17 May 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31790375Vlachopoulos 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 20197424Bramwell 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 33019108Block 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoplethysmographic Measurements of Pulse Wave Velocity (PWV) and Blood Pressure (BP) MEPPAVOP
- ClinicalTrials.gov ID
- NCT05393401
- Acronym / sponsor ID
- MEPPAVOP / 38RC21.0460
- Conditions
- Healthy Volunteers
- Keywords
- Photoplethysmography, Pulse Wave Velocity (PWV), Blood Pressure (BP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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"
| Arm | Type | Receives |
|---|---|---|
| VOP1k | Experimental | Device: VOP1kMedical Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOP1kPhotoplethysmographic records | Device | VOP1k |
Primary outcome
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.
Time frame: 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. "
5 secondary outcomes
Determination of the most adequate distance between the sensors for measuring PWV
Time frame: 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)
Time frame: 4 hours
Determination of the most adequate algorithm to obtain BP values from PWV
Time frame: 4 hours
Check that the signal processing makes it possible to adapt to physiological variations in BP in the same individual
Time frame: 4 hours
Check that the signal processing to obtain the BP can be adapted to different individuals
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 31790375Sharman 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.
- Background: PubMed 20197424Vlachopoulos 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.
- BackgroundBramwell C, Hill and AV, The Velocity of the Pulse Wave in Man, Proc. R. Soc. Lond. B 1922 93, 298-306
- Background: PubMed 33019108Lubin 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.
- Background: PubMed 33009445Block 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOP1k in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel ANGLADE, MD, PhD (04 38 78 17 46, danglade@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393401, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.