A clinical trial to validate the MCPM (Multi-parameter Combined Physiological Signal-based Monitoring), in estimating physiological activity level, at rest, previous and following stimuli.
The Multi-parameter Combined Physiological Signal-based Monitoring (MCPM) system is a non-invasive multi-parameter physiological monitoring system, intended for continuous . acquisition, analysis and display of physiological signals and a Combined Physiological Activity Index (CPAI). Subjects who meet the study inclusion and exclusion criteria will be enrolled to the study and their physiological measures, at rest and during exposure to the thermal and stressogenic physical stimuli will be recorded by the MCPM system. All subjects will be recorded according to a standard procedure; subjects will be lying in the supine position and will be instructed to avoid any movements. The experimenter will connect the sensors (MCPM finger probe). During the experimental session, different thermal stimuli will be administrated via the cold pressor test, with 10-20 minutes of non-stimuli interval. The last stimuli is an stressogenic physical preformed by the subject. 1-2 weeks following the first visit, about half of the subjects will be invited to a second visit, identical study visit, to assess the between session test-retest reliability of the signals. During the second visit, CPAI will be measured again under randomize thermal stimuli and an additional 3 Celsius degrees cold stimuli.
Study Type
OBSERVATIONAL
Enrollment
70
Haifa University
Haifa, Israel
Performance of the CPAI Index
differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli.
Time frame: 6 months
Accuracy of the physiological parameters of the MCPM
comparison to a gold standard device (GE and Procomp system)
Time frame: 6 months
Test re-test reliability
comparison of two repeated CPAI and physiological parameters measures of the same individual at two different study visits
Time frame: 6 months
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