Healthy SubjectsNCT03508063
Monitoring Changes in Physiological Parameters by Utilization of the Combined Physiological Activity Index (CPAI)
An observational study of Healthy Subjects, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Dec 2017to 21 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy subjects, age: 18-65.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Physiological Activity Cause by Changes in Physiological Parameters Via 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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy population | Healthy subjects receiving stimuli (thermal stimuli and stressogenic physical stimuli) at rest, and being monitored MCPM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the CPAI Index
differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli.
Measured: 6 months
Secondary outcomes (2)
Accuracy of the physiological parameters of the MCPM
comparison to a gold standard device (GE and Procomp system)
Measured: 6 months
Test re-test reliability
comparison of two repeated CPAI and physiological parameters measures of the same individual at two different study visits
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start20 Dec 2017
- Primary completion21 May 2018
- Study completion21 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roi Treister, Dr., Principal investigator, Haifa University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508063
- Sponsor's protocol ID
- CLI-17-01
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Physiological Activity Cause by Changes in Physiological Parameters Via Utilization of the Combined Physiological Activity Index (CPAI)
- ClinicalTrials.gov ID
- NCT03508063
- Acronym / sponsor ID
- CLI-17-01
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 21 May 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy population | – | –Healthy subjects receiving stimuli (thermal stimuli and stressogenic physical stimuli) at rest, and being monitored MCPM. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy subjects, age: 18-65.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of the CPAI Index
Time frame: 6 months
differentiation between periods in which the subjects were exposed to various intensities of thermal stimuli.
2 secondary outcomes
Accuracy of the physiological parameters of the MCPM
Time frame: 6 months
Test re-test reliability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roi Treister, Dr. principal investigator
Haifa University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Medasense Biometrics Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the CPAI Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.