NCT03508063

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Medasense Biometrics Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Timeline

• Start date: 2017-12-20
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2018-04-25
• Last updated: 2019-03-08

Locations

1 site across 1 country: Israel