An interventional study of a set of wearable respiration and cardiac monitoring devices in Motor Activity, sponsored by University Hospital, Grenoble. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Basic science
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.
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.
University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
a set of wearable respiration and cardiac monitoring devices
Device: a set of wearable respiration and cardiac monitoring devices
feasibility of methods for detecting physiological state changes from a set of wearable respiration and cardiac monitoring devices
Also known as: Equivital® from Hidalgo Ltd UK,, VISURESP from RBI Instrumentation France,, Finometer® from Finapres Medical Systems NL
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.
Time frame: up to 24 months
Plan to share: Undecided
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble