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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508063
• Other study ID #: CLI-17-01
• Status: Completed
• Start date: December 20, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: March 2019
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
Israel	Haifa University	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the CPAI Index	differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli.	6 months
Secondary	Accuracy of the physiological parameters of the MCPM	comparison to a gold standard device (GE and Procomp system)	6 months
Secondary	Test re-test reliability	comparison of two repeated CPAI and physiological parameters measures of the same individual at two different study visits	6 months