NCT06742775

Brief Summary

Acquisition of synchronized cardiovascular signals from non-invasive measurements (ECG, photoplethysmography pulse sensors, inductance plethysmography) in healthy volunteers aged from 18 to 75, during spontaneous ventilation with apneas (20 seconds) for a total acquisition time of 30 minutes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2025Feb 2027

First Submitted

Initial submission to the registry

December 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

December 11, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

photoplethysmographyelectrocardiographyinductive plethysmographyPulse Wave Velocity

Outcome Measures

Primary Outcomes (3)

  • Electrocardiogram

    acquisition of ECG signals

    1 hour

  • Photoplethysmography

    acquisition of peripheral and central photoplethysmographic signals with radial, brachial, carotid and femoral sensors

    1 hour

  • inductive plethysmography

    acquisition of abdominal and thoracic section variations with an inductive plethysmographic vest

    1 hour

Secondary Outcomes (1)

  • link between peripheral and central pulse wave velocity

    1 hour

Study Arms (3)

Under 30

Healthy volunteers younger than 30 years

Other: physiological signal acquisitions

Between 30 and 50

Healthy volunteers between 30 and 50 years

Other: physiological signal acquisitions

More than 50

Healthy volunteers older than 50 years

Other: physiological signal acquisitions

Interventions

Subjects will be fitted with non-intrusive devices. In a semi-recumbent position, they will be asked to perform * 10 minutes of resting breathing * 10 cycles consisting of a 20-second apnea, to be performed at the end of inspiration, and 1 minute 40 of breathing (100 seconds). This single participation session will last a total of one hour for the volunteer (equipment, recording, de-equipping), including 30 minutes of acquisition.

Between 30 and 50More than 50Under 30

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 healthy volunteers: 3 groups of 20 volunteers per age category (under 30, between 30 and 50, over 50)

You may qualify if:

  • Men and women between 18 and 75 years of age
  • No acute cardiovascular pathologies less than 2 years old,
  • No chronic cardiovascular pathologies.
  • Stature compatible with the use of the plethysmography T-shirt.
  • Person affiliated to a social security scheme or beneficiary of such a scheme
  • Signed informed consent form

You may not qualify if:

  • Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent).
  • Personnel with a hierarchical link to the principal investigator
  • Subjects excluded from another study,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire TIMC

Grenoble, 38000, France

Location

Related Publications (14)

  • Diaz A, Galli C, Tringler M, Ramirez A, Cabrera Fischer EI. Reference values of pulse wave velocity in healthy people from an urban and rural argentinean population. Int J Hypertens. 2014;2014:653239. doi: 10.1155/2014/653239. Epub 2014 Aug 24.

    PMID: 25215227BACKGROUND
  • Fontecave-Jallon J, Tanguy S. Inductive Plethysmography for aortic Pulse Wave Velocity. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:2711-2714. doi: 10.1109/EMBC44109.2020.9175329.

    PMID: 33018566BACKGROUND
  • Fortier C, Agharazii M. Arterial Stiffness Gradient. Pulse (Basel). 2016 Apr;3(3-4):159-66. doi: 10.1159/000438852. Epub 2015 Sep 2.

    PMID: 27195235BACKGROUND
  • Fortier C, Sidibe A, Desjardins MP, Marquis K, De Serres SA, Mac-Way F, Agharazii M. Aortic-Brachial Pulse Wave Velocity Ratio: A Blood Pressure-Independent Index of Vascular Aging. Hypertension. 2017 Jan;69(1):96-101. doi: 10.1161/HYPERTENSIONAHA.116.08409. Epub 2016 Nov 7.

    PMID: 27821616BACKGROUND
  • Heffernan KS, Stoner L, London AS, Augustine JA, Lefferts WK. Estimated pulse wave velocity as a measure of vascular aging. PLoS One. 2023 Jan 26;18(1):e0280896. doi: 10.1371/journal.pone.0280896. eCollection 2023.

    PMID: 36701358BACKGROUND
  • Yu S, McEniery CM. Central Versus Peripheral Artery Stiffening and Cardiovascular Risk. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1028-1033. doi: 10.1161/ATVBAHA.120.313128. Epub 2020 Mar 19.

    PMID: 32188277BACKGROUND
  • Weber T, Wassertheurer S, Hametner B, Parragh S, Eber B. Noninvasive methods to assess pulse wave velocity: comparison with the invasive gold standard and relationship with organ damage. J Hypertens. 2015 May;33(5):1023-31. doi: 10.1097/HJH.0000000000000518.

    PMID: 25668350BACKGROUND
  • Wang J, Jing C, Hu X, Cui J, Tang Q, Tu L, Zhao S, Huang J, Guo D, Li Y, Xu J. Assessment of aortic to peripheral vascular stiffness and gradient by segmented upper limb PWV in healthy and hypertensive individuals. Sci Rep. 2023 Nov 13;13(1):19859. doi: 10.1038/s41598-023-46932-0.

    PMID: 37963909BACKGROUND
  • Townsend RR, Wilkinson IB, Schiffrin EL, Avolio AP, Chirinos JA, Cockcroft JR, Heffernan KS, Lakatta EG, McEniery CM, Mitchell GF, Najjar SS, Nichols WW, Urbina EM, Weber T; American Heart Association Council on Hypertension. Recommendations for Improving and Standardizing Vascular Research on Arterial Stiffness: A Scientific Statement From the American Heart Association. Hypertension. 2015 Sep;66(3):698-722. doi: 10.1161/HYP.0000000000000033. Epub 2015 Jul 9. No abstract available.

    PMID: 26160955BACKGROUND
  • Sztrymf B, Jacobs F, Chemla D, Richard C, Millasseau SC. Validation of the new Complior sensor to record pressure signals non-invasively. J Clin Monit Comput. 2013 Dec;27(6):613-9. doi: 10.1007/s10877-013-9477-y. Epub 2013 May 17.

    PMID: 23681924BACKGROUND
  • Salvi P, Valbusa F, Kearney-Schwartz A, Labat C, Grillo A, Parati G, Benetos A. Non-Invasive Assessment of Arterial Stiffness: Pulse Wave Velocity, Pulse Wave Analysis and Carotid Cross-Sectional Distensibility: Comparison between Methods. J Clin Med. 2022 Apr 15;11(8):2225. doi: 10.3390/jcm11082225.

    PMID: 35456316BACKGROUND
  • Salvi P, Lio G, Labat C, Ricci E, Pannier B, Benetos A. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004 Dec;22(12):2285-93. doi: 10.1097/00004872-200412000-00010.

    PMID: 15614022BACKGROUND
  • Obeid H, Khettab H, Marais L, Hallab M, Laurent S, Boutouyrie P. Evaluation of arterial stiffness by finger-toe pulse wave velocity: optimization of signal processing and clinical validation. J Hypertens. 2017 Aug;35(8):1618-1625. doi: 10.1097/HJH.0000000000001371.

    PMID: 28379892BACKGROUND
  • Karimpour P, May JM, Kyriacou PA. Photoplethysmography for the Assessment of Arterial Stiffness. Sensors (Basel). 2023 Dec 17;23(24):9882. doi: 10.3390/s23249882.

    PMID: 38139728BACKGROUND

Study Officials

  • Stéphane TANGUY

    University Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 19, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations