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Completed

NCT Number: NCT03508063

Monitoring Changes in Physiological Parameters by 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haifa University

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Performance of the CPAI Index

    Time frame: 6 months

    differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli.

Secondary outcomes

  1. Accuracy of the physiological parameters of the MCPM

    Time frame: 6 months

    comparison to a gold standard device (GE and Procomp system)

  2. Test re-test reliability

    Time frame: 6 months

    comparison of two repeated CPAI and physiological parameters measures of the same individual at two different study visits

Sponsors and collaborators

Lead sponsor

Medasense Biometrics Ltd

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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