Development of Tools for Respiration and Circulation Exploration

Study Overview
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Brief Summary
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This study is aimed to develop analysis methods and measurements tools for physiological variables : respiration, circulation and their mutual interactions and with the functions involved in the daily life in healthy volunteers (drinking, eating, sleeping, coughing...). The devices that are used are non invasive. The development of these tools needs to be validated on physiological signals obtained in healthy volunteers.

Detailed Description
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The analysis and interpretation of a record consist, for example, to measure the amplitude of the respiratory modulation of the cardiac period, a witness of the level of the subject's sympathetic activity. To do this, a mathematical model of this oscillation is adjusted on the experimental data, and its characteristics (amplitude, phase, non-linearity...) are considered indexes of the interaction to be compared with the same characteristics in other conditions. The transition to clinical applications requires validation of the developed tools on physiological signals recorded on healthy volunteers in a non-clinical environment, avoiding extra psychological stress in the Protocol followed. Whether it is for the development of tools or their validation, it is essential that the sensors used are non-invasive. Recorded situations are those of everyday life, such as working (only sedentary work are envisaged), eat, talk, rest and move from one place of life to another one.

Official Title
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Development of Tools for Respiration and Circulation Studies and Exploration, Their Mutual Interactions and the Functions Involved in the Daily Life in Healthy Volunteers

Conditions
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Motor Activity

Intervention / Treatment
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* Device: a set of wearable respiration and cardiac monitoring devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy, major and socially insured human subjects Exclusion Criteria: deprived of liberty, hospitalized and protected human subjects

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteers in daily life activities<br>a set of wearable respiration and cardiac monitoring devices | Device: a set of wearable respiration and cardiac monitoring devices<br>* feasibility of methods for detecting physiological state changes from a set of wearable respiration and cardiac monitoring devices<br>* Other names: Finometer® from Finapres Medical Systems NL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and use of developed methods and tools in clinical or fundamental research protocols or in systems for physiological monitoring in humans | The new tools for identification and monitoring of the physiological state of a subject will be developed from a set of non-invasive measures at rest. Resulting physiological state identification will then be validated on registrations on the same subjects in different daily life circumstances. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, Physiological variables : respiration and circulation