Evolution of the Relationship Between Central and Peripheral Arterial Wave Velocities as a Function of Age (EvolVOAge)

December 18, 2024 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Under 30
Healthy volunteers younger than 30 years
Other: physiological signal acquisitions

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 50
Healthy volunteers between 30 and 50 years
Other: physiological signal acquisitions

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.
More than 50
Healthy volunteers older than 50 years
Other: physiological signal acquisitions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiogram
Time Frame: 1 hour
acquisition of ECG signals
1 hour
Photoplethysmography
Time Frame: 1 hour
acquisition of peripheral and central photoplethysmographic signals with radial, brachial, carotid and femoral sensors
1 hour
inductive plethysmography
Time Frame: 1 hour
acquisition of abdominal and thoracic section variations with an inductive plethysmographic vest
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
link between peripheral and central pulse wave velocity
Time Frame: 1 hour
Assesment of the link between peripheral and central vascular function with statistical analysis (Linear regression, Bland and Altman test)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

Investigators

  • Principal Investigator: Stéphane TANGUY, University Grenoble alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC24.0299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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