Monitoring Changes in Physiological Parameters by Utiliza... | NCT03508063

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

NCT03508063

Sponsor

Medasense Biometrics Ltd

Status

Completed

Last Update Posted

Mar 8, 2019Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Healthy Subjects

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2017Actual

Primary Completion Date

May 21, 2018Actual

Completion Date

May 21, 2018Actual

First Submitted Date

Mar 22, 2018

First Submission Date that Met QC Criteria

Apr 15, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2019

Last Update Posted Date

Mar 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy population		Healthy subjects receiving stimuli (thermal stimuli and stressogenic physical stimuli) at rest, and being monitored MCPM.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance of the CPAI Index	differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Accuracy of the physiological parameters of the MCPM	comparison to a gold standard device (GE and Procomp system)	6 months
Test re-test reliability	comparison of two repeated CPAI and physiological parameters measures of the same individual at two different study visits

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

healthy subjects, age: 18-65.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roi Treister, Dr.	Haifa University, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haifa University		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided