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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Haifa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

healthy subjects, age: 18-65.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy population; Healthy subjects receiving stimuli (thermal stimuli and stressogenic physical stimuli) at rest, and being monitored MCPM.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Investigators: Principal Investigator: Roi Treister, Dr., Haifa University, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): May 21, 2018
• Study Completion (Actual): May 21, 2018

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: April 15, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CLI-17-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No