NCT03508063

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

March 22, 2018

Last Update Submit

March 7, 2019

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Performance of the CPAI Index

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

    6 months

Secondary Outcomes (2)

  • Accuracy of the physiological parameters of the MCPM

    6 months

  • Test re-test reliability

    6 months

Study Arms (1)

Healthy population

Healthy subjects receiving stimuli (thermal stimuli and stressogenic physical stimuli) at rest, and being monitored MCPM.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy subjects, age: 18-65.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haifa University

Haifa, Israel

Location

Study Officials

  • Roi Treister, Dr.

    Haifa University, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 25, 2018

Study Start

December 20, 2017

Primary Completion

May 21, 2018

Study Completion

May 21, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)