Monitoring Changes in Physiological Parameters by Utilization of the Combined Physiological Activity Index (CPAI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Monitoring Physiological Activity Cause by Changes in Physiological Parameters Via Utilization of the Combined Physiological Activity Index (CPAI)

Conditions
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Healthy Subjects

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 < 65 years old Signing an Informed Consent Form (ICF) Healthy participant No medication/drugs were taken in the last week No usage of chronic medication in the last 3 months (except non-pregnancy pills) Blood Pressure < (90,140), Heart Rate < 100pps at rest No alcohol usage during the last 48 hours Exclusion Criteria: Medication/drugs were taken in the last week (not including non-pregnancy pills) Alcohol usage during the last 48 hours Caffeine and smoking in the last 3 hours Pregnant women Inability to comply with the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy population<br>Healthy subjects receiving stimuli (thermal stimuli and stressogenic physical stimuli) at rest, and being monitored MCPM. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the CPAI Index | differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the physiological parameters of the MCPM | comparison to a gold standard device (GE and Procomp system) | 6 months | 
| Test re-test reliability | comparison of two repeated CPAI and physiological parameters measures of the same individual at two different study visits | 6 months |