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临床试验/NCT03508063
NCT03508063已完成不适用

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

Medasense Biometrics Ltd1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Performance of the CPAI Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Performance of the CPAI Index

时间窗: 6 months

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

次要结局

  • Accuracy of the physiological parameters of the MCPM(6 months)
  • Test re-test reliability(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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