Clinical trial NCT03508063: Monitoring Changes in Physiological Parameters by Utilization of the Combined Physiological Activity Index (CPAI)
Official title: Monitoring Physiological Activity Cause by Changes in Physiological Parameters Via Utilization of the Combined Physiological Activity Index (CPAI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects, age: 18-65.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance of the CPAI Index
timeFrame: 6 months
Secondary outcomes:
measure: Accuracy of the physiological parameters of the MCPM
timeFrame: 6 months
measure: Test re-test reliability
timeFrame: 6 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Haifa University
Study officials:
affiliation: Haifa University, Israel
name: Roi Treister, Dr.
role: PRINCIPAL_INVESTIGATOR
References: