Stress, PhysiologicalcodesnaNCT02754323
Feasibility Study and Validation of Measuring Apparatus Codesna Stress at Work
A study testing Apparatus CODESNA in people with Stress, Physiological, run by Centre Hospitalier Universitaire de Nice.
Trial summary
There are different definitions of stress according to each discipline. In psychology, it is defined according to the individual's ability to adapt. The medical approach focuses on the reactions of the body to stress situations. And the organizational approach seeks to define in terms of sources of stress situations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological
- What is being tested?
- Apparatus CODESNA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signature of informed consent
- Belong to a social security scheme
- Working at the University Hospital of Nice
Who cannot join
- occurrence of an event particularly disturbing staff during the last six months
- raises annual leave of more than seven days in the last month
About this study
There are different definitions of stress according to each discipline. In psychology, it is defined according to the individual's ability to adapt. The medical approach focuses on the reactions of the body to stress situations. And the organizational approach seeks to define in terms of sources of stress situations. According to a national interprofessional agreement on stress at work in 2008 is defined as a condition that occurs when there is an imbalance between the perception of a person with constraints imposed by its environment and the perception that it has its own resources to cope.
Stress at work
Read more
INRS emphasizes prevention to fight against the cost of work stress and seeks to develop methods and tools objectification stressful situations. The social cost of workplace stress would represent 10 to 20% of the expenses of the branch for employment injuries / occupational diseases of the Social Security According to a survey by the European Agency for Safety and Health at Work conducted in 1999, stress is the cause of 50 to 60% of all lost working days. The cost of occupational stress assessed by INRS represent 830 million euros in 2000 in France.
Media coverage of working conditions related suicides has prompted some companies to communicate about work stress and develop actions.
According to the study of Sumer in 2003, 61% of employees have a highly stressful job and 27% complained of work-related health problems.
However, the 2009 survey shows that job stress is a major risk factor for mental health and is associated with decreased job performance. Burnout sets in stages idealistic enthusiasm, stagnation, frustration, apathy. Therefore, it is essential to track the state of chronic stress as soon as possible to prevent burnout.
Stress testing procedures
The major problem is that there is not now comprehensively measure of stress. The measurement models that are available to date, all incomplete, can be classified according to two categories.
First, the general patterns that measure only partially stress but which can be used in any type of fields. One application of self-KARASEK and the imbalance of effort / reward SIEGRIST. These two models are mainly used for epidemiological studies on job stress.
Second, the specific models that provide a more comprehensive measure but we can only use in the area from which they come. These measure specific stressors (organizational, professional and emotional) in the study population.
The main objective of this study is evaluate the feasibility and validate the measurement of chronic stress by CODESNA tool. The method is to compare the measured result by the CODESNA tool to measure stress questionnaires collected by the Maslach Burnout INVENTORY and KARASEK. This method explores finely enough constraints and allows a comparison of national data.
- Conditions
- Stress, Physiological
- Being tested
- Apparatus CODESNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apparatus CODESNADevice
The inclusion period is evaluated at one month and the participation of each patient is two days. One day or the subject performs the evaluation of chronic stress by CODESNA and following through questionnaires and another day to 3 weeks / one month apart, to perform a second chronic stress measurement with tool CODESNA to evaluate its reproducibility and reliability.
| Study group | Role | What they receive |
|---|---|---|
| apparatus CODESNA | Other | correlation between job stress measurement by the Maslach Burnout INVENTORY and KARASEK questionnaires and measurement of chronic stress by CODESNA tool Receives: Device: Apparatus CODESNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the measured result by the CODESNA tool
The result of chronic Stress is expressed in% above the value 100. It measures the chronic stress in a universal scale for all human beings and using as reference the balance point of the autonomic nervous system.
This shall be measured from the recording of R-R intervals of an ECG, also called Heart Rate Variability (HRV),,. Then the CODESNA algorithms perform mathematical processing being based physiological principle to deliver information Chronic Stress
Measured: 1 month
the measured stress questionnaires collected by the Maslach Burnout INVENTORY scale
The result of the Maslach Burnout INVENTORY scale is a score
Measured: 1 Month
the measured stress questionnaires collected by the KARASEK scale
The result of the KARASEK scale is a score
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754323
- Sponsor's protocol ID
- 15-AOI-08
- Other IDs
- 2015-A00512-47
- Acronym
- codesna
- Status last verified
- Nov 2025
- First submitted
- 20 Apr 2016
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study and Validation of Measuring Apparatus Codesna Stress at Work
- ClinicalTrials.gov ID
- NCT02754323
- Acronym / sponsor ID
- codesna / 15-AOI-08
- Conditions
- Stress, Physiological
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
There are different definitions of stress according to each discipline. In psychology, it is defined according to the individual's ability to adapt. The medical approach focuses on the reactions of the body to stress situations. And the organizational approach seeks to define in terms of sources of stress situations. According to a national interprofessional agreement on stress at work in 2008 is defined as a condition that occurs when there is an imbalance between the perception of a person with constraints imposed by its environment and the perception that it has its own resources to cope.
Stress at work
INRS emphasizes prevention to fight against the cost of work stress and seeks to develop methods and tools objectification stressful situations. The social cost of workplace stress would represent 10 to 20% of the expenses of the branch for employment injuries / occupational diseases of the Social Security According to a survey by the European Agency for Safety and Health at Work conducted in 1999, stress is the cause of 50 to 60% of all lost working days. The cost of occupational stress assessed by INRS represent 830 million euros in 2000 in France.
Media coverage of working conditions related suicides has prompted some companies to communicate about work stress and develop actions.
According to the study of Sumer in 2003, 61% of employees have a highly stressful job and 27% complained of work-related health problems.
However, the 2009 survey shows that job stress is a major risk factor for mental health and is associated with decreased job performance. Burnout sets in stages idealistic enthusiasm, stagnation, frustration, apathy. Therefore, it is essential to track the state of chronic stress as soon as possible to prevent burnout.
Stress testing procedures
The major problem is that there is not now comprehensively measure of stress. The measurement models that are available to date, all incomplete, can be classified according to two categories.
First, the general patterns that measure only partially stress but which can be used in any type of fields. One application of self-KARASEK and the imbalance of effort / reward SIEGRIST. These two models are mainly used for epidemiological studies on job stress.
Second, the specific models that provide a more comprehensive measure but we can only use in the area from which they come. These measure specific stressors (organizational, professional and emotional) in the study population.
The main objective of this study is evaluate the feasibility and validate the measurement of chronic stress by CODESNA tool. The method is to compare the measured result by the CODESNA tool to measure stress questionnaires collected by the Maslach Burnout INVENTORY and KARASEK. This method explores finely enough constraints and allows a comparison of national data.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apparatus CODESNA | Other | Device: Apparatus CODESNAcorrelation between job stress measurement by the Maslach Burnout INVENTORY and KARASEK questionnaires and measurement of chronic stress by CODESNA tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signature of informed consent
- Belong to a social security scheme
- Working at the University Hospital of Nice
Key exclusion criteria (2 listed)
- occurrence of an event particularly disturbing staff during the last six months
- raises annual leave of more than seven days in the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apparatus CODESNAThe inclusion period is evaluated at one month and the participation of each patient is two days. One day or the subject performs the evaluation of chronic stress by CODESNA and following through questionnaires and another day to 3 weeks / one month apart, to perform a second chronic stress measurement with tool CODESNA to evaluate its reproducibility and reliability. | Device | apparatus CODESNA |
Primary outcome
the measured result by the CODESNA tool
Time frame: 1 month
The result of chronic Stress is expressed in% above the value 100. It measures the chronic stress in a universal scale for all human beings and using as reference the balance point of the autonomic nervous system. This shall be measured from the recording of R-R intervals of an ECG, also called Heart Rate Variability (HRV),,. Then the CODESNA algorithms perform mathematical processing being based physiological principle to deliver information Chronic Stress
the measured stress questionnaires collected by the Maslach Burnout INVENTORY scale
Time frame: 1 Month
The result of the Maslach Burnout INVENTORY scale is a score
the measured stress questionnaires collected by the KARASEK scale
Time frame: 1 month
The result of the KARASEK scale is a score
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Related trials for Stress, Physiological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Not yet recruiting
Eye Covering and White Noise During Nasogastric Tube Insertion in Preterm Infants
Preterm Infants
Recruiting
Effects of Moderate Exercise and Cyclic Sighing on Stress, Cognition and Physiological Markers in Young Adults
Stress
Not yet recruiting
Psychological and Physiological Effects of Three-Minute Breathing Space Meditation in UPM Postgraduate Students
Stress, Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Apparatus CODESNA in people with Stress, Physiological, run by Centre Hospitalier Universitaire de Nice.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
the measured result by the CODESNA tool (time frame: 1 month). The study lists 3 primary outcomes in all. 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 2 Dec 2025.