Evaluation in Healthy Volunteers of CARDIOSPACE II

Study Overview
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Brief Summary
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The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment. Electrocardiogram Vascular doppler Laser doppler with iontophoresis Continuous blood pressure recording at the finger level Brachial blood pressure Ultrasound Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder

Official Title
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Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space

Conditions
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Healthy

Intervention / Treatment
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* Device: Test of the different devices integrated in cardiospace II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Height between 160 et 180 cm Body mass index between 18 et 24 Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest Normal electrocardiogram Possibility to perform transcranial doppler Able to understand aims and constraints of this study National health insurance Signature of the informed consent form Exclusion Criteria: Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding Participating at the time to another clinical trial investigating Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation) Taking any chronic treatment Any sign of cardiovascular or respiration disease Any sign of syncopal events by questioning (>2 events per year) Contraindication to perform physical activity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARDIOSPACE II<br>Test of the different devices integrated in cardiospace II. | Device: Test of the different devices integrated in cardiospace II<br>* The different devices included in CARDIOSPACE II will be tested Electrocardiogram Vascular Doppler LaserDoppler and iontophoresis Brachial blood pressure Continuous blood pressure recorded at the finger level Ultrasound Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of the ECG signal given by CARDIOSPACE II: scale | ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise | Through study completion, an average of 6 months | 
| Quality of the vascular Doppler signal: scale | Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise | Through study completion, an average of 6 months | 
| Quality of the laser doppler signal: scale | Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise | Through study completion, an average of 6 months | 
| Quality of the ultrasound images: scale | Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image | Through study completion, an average of 6 months | 
| Quality of the blood pressure wave: scale | Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise | Through study completion, an average of 6 months | 
| Quality of the ambulatory measurements (ECG / SAO2) | ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise | Through study completion, an average of 6 months |