Healthy
Conditions
Brief summary
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
Interventions
DEVICETest of the different devices integrated in cardiospace II
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)
Sponsors
Centre National des Etudes Spatiales - French Space Agency (CNES)
Astronautic Center of China (ACC)
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of the ECG signal given by CARDIOSPACE II: scale | Through study completion, an average of 6 months | 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 |
| Quality of the vascular Doppler signal: scale | Through study completion, an average of 6 months | 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 |
| Quality of the laser doppler signal: scale | Through study completion, an average of 6 months | 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 |
| Quality of the ultrasound images: scale | Through study completion, an average of 6 months | 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 |
| Quality of the blood pressure wave: scale | Through study completion, an average of 6 months | 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 |
| Quality of the ambulatory measurements (ECG / SAO2) | Through study completion, an average of 6 months | 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 |
Countries
France
Outcome results
None listed