StressJOBSTRESS-OPHNCT04959838
JOB STRESS in OPHthalmology Physicians and Residents
A study testing Impact of prolonged work in people with Stress and Heart Rate Variability, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Ophthalmology physicians and residents work under stress conditions during night emergency ophthalmology shifts. Under time pressure, that is a characteristic of the urgency of care, they must use all their cognitive resources to make an accurate diagnosis and to provide accurate decisions, with sometimes surgical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress, Heart Rate Variability
- What is being tested?
- Impact of prolonged work
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2021to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ophthalmologists defined as physicians who completed the ophthalmology DES (Specialized studies diploma), as well as ophthalmology residents defined as a resident registered in the ophthalmology DES working during the inclusion period in the ophthalmology department of the university hospital center of Clermont-Ferrand.
- Ability to give a written informed consent to participate in research.
- Affiliation to a social security system.
- Age between 18 and 65 years old
Who cannot join
- Participant refusal to participate
- Children under the age of 18, pregnant and breastfeeding women, protected adults (individuals under guardianship by court order), adults deprived of their liberty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Frédéric DUTHEIL
About this study
Official title: Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents
Ophthalmology physicians and residents work under stress conditions during night emergency ophthalmology shifts. Under time pressure, that is a characteristic of the urgency of care, they must use all their cognitive resources to make an accurate diagnosis and to provide accurate decisions, with sometimes surgical emergency acts. In addition, in France, they work at night following by an usual day work, and they can also work 48 consecutive hours during weekends, followed by a work day … i.e. 60 consecutive hours of work … Long working hours with a short recovery time has been demonstrated to be a major factor of stress and fatigue. Even if not demonstrated on ophthalmologists, those working conditions may contribute to symptoms of mental exhaustion and physical fatigue (sleep deprivation), often accompanied by a loss of motivation at work. This may leads to a feeling of loss of time control; stress can also distort the perception of time and leads to hasty actions or delayed decision-making. The combined effects of stress, feelings of loss of time control, and fatigue necessarily have an impact on work performance and work quality, with a high risk of medical error. Moreover, prolonged stress may expose ophthalmologists to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease.
The main hypothesis is that prolonged work (up to 60 consecutive working hours) may impact on HRV, comparatively to a typical working day.
Read the detailed description
The JOBSTRESS.OPH protocol was designed to study the impact of prolonged work (up to 60 consecutive working hours) on HRV, comparatively to a typical working day. Each residents and / or ophthalmology physicians participates up to a maximum of 5 times. Participants wears a heart rate belt and a watch that measures physical activity and skin conductance for 34 hours straight. Participants only wears an EEG monitor while sleeping to assess its quality. At the end of the evaluation session, a simulator test mimicking the successive stages of cataract surgery is performed, as well as the performance of saliva tests. Short quality of life assessment questionnaires are completed at the start and end of the day, supplemented by a general questionnaire completed only once during the study.
Statistical analysis will be performed using Stata software (v15, Stata-Corp, College Station, US). Categorical parameters will be described in terms of numbers and frequencies, whereas continuous variables will be expressed as mean and standard deviation or median and [inter-quartile range] according to statistical distribution. All statistical tests will be two-sided and p<0.05 will be considered significant. Graphic representations will be complete presentations of results.
Investigators process multivariate physiological series (HRV, SC, biomarkers) in order to build a stress index. For such multivariate physiological series, investigators first use change point analysis on each univariate series in order to get clusters with constant parameters, then investigators use classification algorithm on the constant parameters obtained in first step in order to obtain different classes corresponding to different levels of stress. Eventually, investigators obtain at each time the level of stress and can compare it to the environmental conditions.
- Conditions
- Stress, Heart Rate Variability
- Being tested
- Impact of prolonged work
- Keywords
- ophthalmologists, on-call duty, stress, surgical simulator, heart rate variability, sleep, questionnaires, actimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of prolonged workBehavioural
Evaluate the impact of prolonged work (up to 60 consecutive hours) on the surgical capacities evaluated on a simulator, as well as on stress markers (questionnaires, saliva assays, skin conductance, quality of sleep) compared to a standard day.
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmology physicians and residents | Experimental | Ophthalmology physicians and residents will be followed during 34h, from 8 am to 6 pm the following day,in five different conditions:
* Control day (no work)
* Typical working day
* Working day + one night shift
* Emergency working day + two consecutive night shifts
* Night shift. Receives: Behavioral: Impact of prolonged work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
HRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored.
Measured: During 34 hours in the five different conditions
Secondary outcomes (44)
change in stress levels
measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in stress levels
measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in fatigue levels
measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in fatigue levels
measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in burnout levels
measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in burnout levels
measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in depression levels
measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in depression levels
measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in anxiety levels
measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in anxiety levels
measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in "Job demand control support" levels
measure of job demand, job control and support levels using visual analogue scale of 100 mm, from 0 to 100. Higher scores of demand mean a worse level. Higher scores of control and support mean a better level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in "Job demand control support" levels
measure of job demand, job control and support levels using visual analogue scale of 100 mm, from 0 to 100. Higher scores of demand mean a worse level. Higher scores of control and support mean a better level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in "Effort reward imbalance" levels
measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in "Effort reward imbalance" levels
measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in work addiction levels
measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in work addiction levels
measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in sleep quality
measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in sleep quality
measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Measured: at 6pm, end of the 34 hours follow-up, in the five different conditions
Saliva biomarkers cortisol
measure on Cortisol
Measured: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers cortisol
measure on Cortisol
Measured: 24hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers dheas
measure on dheas
Measured: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers dheas
measure on dheas
Measured: 24 hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers lgAs
measure on lgAs
Measured: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers lgAs
measure on lgAs
Measured: 24 hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers Leptine
measure on Leptine
Measured: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers Leptine
measure on Leptine
Measured: 24 hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers Ghrelin
measure on Ghrelin
Measured: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers Ghrelin
measure on Ghrelin
Measured: 24 hours after the beginning of the procedure, in the five different conditions
Declared level of physical activity
Physical activity is assessed with one question
Measured: once at 8am, at the beginning of the procedure
Level of physical activity
Physical activity is assessed with a 3-Axis accelerometer
Measured: during 34 hours, in the five different conditions
Level of sedentary
Sedentary is assessed regarding the time spent sitting assessed with one question
Measured: once at 8am, at the beginning of the procedure
Food intake
assessing food intake with ingesta
Measured: 34 hours recording, in the five different conditions
Sick leave
assessing the number of absence days the previous 6 months using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Height
measure of height in cm using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Weight
measure of weight in kilograms using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Age
measure of age in years using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Gender
measure of gender using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Qualification
measure of qualification using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Personal status
measure of personal status using a questionnaire
Measured: once at 8amat the beginning of the procedure
Lifestyle
Assessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire
Measured: once at 8am, at the beginning of the procedure
Skin conductance
measure of the skin conductance using Wrist band electrodes
Measured: during 34 hours , in the five different conditions
Sleep quality
measure of sleep quality using Sleep profiler
Measured: measure for about 7 hours the night of the control day (no work)
Sleep quality
measure of sleep quality using Sleep profiler
Measured: measure for about 7 hours during the night of the typical working day
Surgical performance
assessing surgical performance using a high-end virtual reality simulator for intraocular surgery training
Measured: Once at 6pm, at the end of the 34 hours follow-up , in the five different conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start6 Jul 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne, LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France
- Responsible party
- Sponsor
- Investigators
- Frédéric DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959838
- Sponsor's protocol ID
- RBHP 2020 DUTHEIL 2
- Other IDs
- 2020-A03231-38
- Acronym
- JOBSTRESS-OPH
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2021
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents
- ClinicalTrials.gov ID
- NCT04959838
- Acronym / sponsor ID
- JOBSTRESS-OPH / RBHP 2020 DUTHEIL 2
- Conditions
- Stress, Heart Rate Variability
- Keywords
- ophthalmologists, on-call duty, stress, surgical simulator, heart rate variability, sleep, questionnaires, actimetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne, LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Jul 2021 (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.
Ophthalmology physicians and residents work under stress conditions during night emergency ophthalmology shifts. Under time pressure, that is a characteristic of the urgency of care, they must use all their cognitive resources to make an accurate diagnosis and to provide accurate decisions, with sometimes surgical emergency acts. In addition, in France, they work at night following by an usual day work, and they can also work 48 consecutive hours during weekends, followed by a work day … i.e. 60 consecutive hours of work … Long working hours with a short recovery time has been demonstrated to be a major factor of stress and fatigue. Even if not demonstrated on ophthalmologists, those working conditions may contribute to symptoms of mental exhaustion and physical fatigue (sleep deprivation), often accompanied by a loss of motivation at work. This may leads to a feeling of loss of time control; stress can also distort the perception of time and leads to hasty actions or delayed decision-making. The combined effects of stress, feelings of loss of time control, and fatigue necessarily have an impact on work performance and work quality, with a high risk of medical error. Moreover, prolonged stress may expose ophthalmologists to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease.
The main hypothesis is that prolonged work (up to 60 consecutive working hours) may impact on HRV, comparatively to a typical working day.
Detailed description
The JOBSTRESS.OPH protocol was designed to study the impact of prolonged work (up to 60 consecutive working hours) on HRV, comparatively to a typical working day. Each residents and / or ophthalmology physicians participates up to a maximum of 5 times. Participants wears a heart rate belt and a watch that measures physical activity and skin conductance for 34 hours straight. Participants only wears an EEG monitor while sleeping to assess its quality. At the end of the evaluation session, a simulator test mimicking the successive stages of cataract surgery is performed, as well as the performance of saliva tests. Short quality of life assessment questionnaires are completed at the start and end of the day, supplemented by a general questionnaire completed only once during the study.
Statistical analysis will be performed using Stata software (v15, Stata-Corp, College Station, US). Categorical parameters will be described in terms of numbers and frequencies, whereas continuous variables will be expressed as mean and standard deviation or median and [inter-quartile range] according to statistical distribution. All statistical tests will be two-sided and p<0.05 will be considered significant. Graphic representations will be complete presentations of results.
Investigators process multivariate physiological series (HRV, SC, biomarkers) in order to build a stress index. For such multivariate physiological series, investigators first use change point analysis on each univariate series in order to get clusters with constant parameters, then investigators use classification algorithm on the constant parameters obtained in first step in order to obtain different classes corresponding to different levels of stress. Eventually, investigators obtain at each time the level of stress and can compare it to the environmental conditions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmology physicians and residents | Experimental | Behavioral: Impact of prolonged workOphthalmology physicians and residents will be followed during 34h, from 8 am to 6 pm the following day,in five different conditions: * Control day (no work) * Typical working day * Working day + one night shift * Emergency working day + two consecutive night shifts * Night shift. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ophthalmologists defined as physicians who completed the ophthalmology DES (Specialized studies diploma), as well as ophthalmology residents defined as a resident registered in the ophthalmology DES working during the inclusion period in the ophthalmology department of the university hospital center of Clermont-Ferrand.
- Ability to give a written informed consent to participate in research.
- Affiliation to a social security system.
- Age between 18 and 65 years old
Key exclusion criteria (2 listed)
- Participant refusal to participate
- Children under the age of 18, pregnant and breastfeeding women, protected adults (individuals under guardianship by court order), adults deprived of their liberty.
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 |
|---|---|---|
| Impact of prolonged workEvaluate the impact of prolonged work (up to 60 consecutive hours) on the surgical capacities evaluated on a simulator, as well as on stress markers (questionnaires, saliva assays, skin conductance, quality of sleep) compared to a standard day. | Behavioural | Ophthalmology physicians and residents |
Primary outcome
Heart rate variability
Time frame: During 34 hours in the five different conditions
HRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored.
44 secondary outcomes
change in stress levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in stress levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in fatigue levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in fatigue levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in burnout levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in burnout levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in depression levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in depression levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in anxiety levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in anxiety levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in "Job demand control support" levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in "Job demand control support" levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in "Effort reward imbalance" levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in "Effort reward imbalance" levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in work addiction levels
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in work addiction levels
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
change in sleep quality
Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
change in sleep quality
Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions
Saliva biomarkers cortisol
Time frame: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers cortisol
Time frame: 24hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers dheas
Time frame: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers dheas
Time frame: 24 hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers lgAs
Time frame: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers lgAs
Time frame: 24 hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers Leptine
Time frame: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers Leptine
Time frame: 24 hours after the beginning of the procedure, in the five different conditions
Saliva biomarkers Ghrelin
Time frame: baseline of the 34 hours procedure, in the five different conditions
Saliva biomarkers Ghrelin
Time frame: 24 hours after the beginning of the procedure, in the five different conditions
Declared level of physical activity
Time frame: once at 8am, at the beginning of the procedure
Level of physical activity
Time frame: during 34 hours, in the five different conditions
Level of sedentary
Time frame: once at 8am, at the beginning of the procedure
Food intake
Time frame: 34 hours recording, in the five different conditions
Sick leave
Time frame: once at 8am, at the beginning of the procedure
Height
Time frame: once at 8am, at the beginning of the procedure
Weight
Time frame: once at 8am, at the beginning of the procedure
Age
Time frame: once at 8am, at the beginning of the procedure
Gender
Time frame: once at 8am, at the beginning of the procedure
Qualification
Time frame: once at 8am, at the beginning of the procedure
Personal status
Time frame: once at 8amat the beginning of the procedure
Lifestyle
Time frame: once at 8am, at the beginning of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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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.
Frédéric DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact of prolonged work in people with Stress and Heart Rate Variability, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: During 34 hours in the five different conditions). 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 16 Jun 2026.