Development of Tools for Respiration and Circulation Exploration
- Conditions
- Motor Activity
- Interventions
- Device: a set of wearable respiration and cardiac monitoring devices
- Registration Number
- NCT02114749
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- healthy, major and socially insured human subjects
- deprived of liberty, hospitalized and protected human subjects
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description volunteers in daily life activities a set of wearable respiration and cardiac monitoring devices a set of wearable respiration and cardiac monitoring devices
- Primary Outcome Measures
Name Time Method Feasibility and use of developed methods and tools in clinical or fundamental research protocols or in systems for physiological monitoring in humans up to 24 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
TIMC - pavillon Taillefer - CHU
🇫🇷GRENOBLE cedex 9, France
University Hospital
🇫🇷Grenoble, France