Shift-Work Sleep DisorderMELACTI-12NCT03153917
Biological Rhythms Impact of 12 Hours Shift Work
A study testing melatonin and cortisol sampling in people with Shift-Work Sleep Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- melatonin and cortisol sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2017to 28 Jul 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nurses or nursing assistants working in the Sleep and Respiratory Diseases Department of the Croix-Rousse Hospital with positions in 12 hours for more than 6 months
- informed consent given by the subject
Who cannot join
- Pregnancy or lactation <6 months
- Taking treatment modifying the secretion of melatonin (melatoninergic drugs (including antidepressants), beta-blockers)
- Refusal of participate
- Minor or major protected subject
- Not affiliated to a social security scheme
- Participant in another interventional study interfering with sleep / wake rhythm or work schedules (judgment of the investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses
Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- melatonin and cortisol sampling
- Keywords
- shift work, melatonin, sleep
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin and cortisol samplingOther
The study will take place over 15 days during which the nurses will wear an actigraphic wristband and will fulfill a sleep log. During 3 periods of 24 hours selected during these 15 days, including a 12h day shift (Day 2), a 12h night shift (Day 8) and a rest (Day 13), the participants will collect their urine by 4 to 8 hour periods, note the corresponding urine volumes and for each period, sample a 5 mL tube which will be analyzed later (6-sulfatoxymelatonin and urinary cortisol assays). The subjects will complete questionnaires at the beginning of the study (Horne and Ostberg, Insomnia Severity Index, Epworth, Pichot, Hospital Anxiety and Depression) and the days corresponding to the urine sampling (Karolinska and St Mary Hospital).
| Study group | Role | What they receive |
|---|---|---|
| melatonin and cortisol sampling | Experimental | 14 healthy volunteer nurses working on 12 hours night/day schedules in the Sleep Medicine Center of Lyon. Receives: Other: melatonin and cortisol sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of melatonin excreted during the sleep period for the night shift
The impact of 12H shift work on melatonin secretion dynamics will be assessed by comparing the total amount of melatonin excreted during the sleep period between the 12h day shift condition and the 12h night shift condition
Measured: at day 8 (night shift)
total amount of melatonin excreted during the sleep period for the day shift.
The impact of 12H shift work on melatonin secretion dynamics will be assessed by comparing the total amount of melatonin excreted during the sleep period between the 12h day shift condition and the 12h night shift condition
Measured: at day 2 (day shift)
Secondary outcomes (43)
Total amount of melatonin excreted during the sleep period at rest
the total amount of melatonin excreted during the sleep period at rest will be compared to the total amount of melatonin excreted during the sleep period for the 12h day shift condition ant to the total amount of melatonin excreted during the sleep period for the 12h night shift condition
Measured: at day 13 (rest)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of total excretion (ng)
Measured: at day 2 (day shift)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of acrophase (h)
Measured: at day 2 (day shift)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of amplitude (ng)
Measured: at day 2 (day shift)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of mesor (ng)
Measured: at day 2 (day shift)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of total excretion (ng)
Measured: at day 8 (night shift)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of acrophase (h)
Measured: at day 8 (night shift)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of amplitude (ng)
Measured: at day 8 (night shift)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of mesor (ng)
Measured: at day 8 (night shift)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of total excretion (ng)
Measured: at day 13 (rest)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of acrophase (h)
Measured: at day 13 (rest)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of amplitude (ng)
Measured: at day 13 (rest)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.
Measure of mesor (ng)
Measured: at day 13 (rest)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of total excretion (ng)
Measured: at day 2 (day shift)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of acrophase (h)
Measured: at day 2 (day shift)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of amplitude (ng)
Measured: at day 2 (day shift)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of mesor (ng)
Measured: at day 2 (day shift)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of total excretion (ng)
Measured: at day 8 (night shift)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of acrophase (h)
Measured: at day 8 (night shift)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of amplitude (ng)
Measured: at day 8 (night shift)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of mesor (ng)
Measured: at day 8 (night shift)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of total excretion (ng)
Measured: at day 13 (rest)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of acrophase (h)
Measured: at day 13 (rest)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of amplitude (ng)
Measured: at day 13 (rest)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.
Measure of mesor (ng)
Measured: at day 13 (rest)
Objective sleep quality
Measure of sleep latency assessed by sleep log
Measured: 15 days
Objective sleep quality
Measure of sleep latency assessed by actigraphy
Measured: 15 days
Objective sleep quality
Measure of sleep efficiency
= total sleep / bedtime assessed by sleep log
Measured: 15 days
Objective sleep quality
Measure of sleep efficiency
= total sleep / bedtime assessed by actigraphy
Measured: 15 days
Objective sleep quality
Measure of fragmentation index assessed by sleep log
Measured: 15 days
Objective sleep quality
Measure of fragmentation index assessed by actigraphy
Measured: 15 days
Objective sleep quality
Measure of intra-sleep wakefulness assessed by sleep log
Measured: 15 days
Objective sleep quality
Measure of intra-sleep wakefulness assessed by actigraphy
Measured: 15 days
Objective sleep duration
duration of sleep assessed by actigraphy
Measured: 15 days
Excessive daytime sleepiness
This outcome will be assessed by the Epworth sleepiness Scale
Measured: at day 1
Asthenia
This outcome will be assessed by the Pichot asthenia scale
Measured: at day 1
Insomnia severity
This outcome will be assessed by the Insomnia Severity Index
Measured: at day 1
Anxiety
This outcome will be assessed by the Hospital Anxiety and Depression scale
Measured: at day 1
Depression
This outcome will be assessed by the Hospital Anxiety and Depression scale
Measured: at day 1
Vigilance at awakening
This outcome will be assessed by the Karolinska scale
Measured: at day 2, 8 and 13
Sleep subjective quality
This outcome will be assessed by the St Mary Hospital Questionary
Measured: at day 2, 8 and 13
Chronotype
This outcome will be assessed by the Horne and Ostberg Questionary
Measured: at day 1
Light exposition
This outcome will be assessed by the actigraphy
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start2 Jun 2017
- Primary completion28 Jul 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Peter Derex, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153917
- Sponsor's protocol ID
- 69HCL16_0624
- Acronym
- MELACTI-12
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 12 Feb 2018
- 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 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses
- ClinicalTrials.gov ID
- NCT03153917
- Acronym / sponsor ID
- MELACTI-12 / 69HCL16_0624
- Conditions
- Shift-Work Sleep Disorder
- Keywords
- shift work, melatonin, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 15 May 2017 (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.
Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| melatonin and cortisol sampling | Experimental | Other: melatonin and cortisol sampling14 healthy volunteer nurses working on 12 hours night/day schedules in the Sleep Medicine Center of Lyon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses or nursing assistants working in the Sleep and Respiratory Diseases Department of the Croix-Rousse Hospital with positions in 12 hours for more than 6 months
- informed consent given by the subject
Key exclusion criteria (6 listed)
- Pregnancy or lactation <6 months
- Taking treatment modifying the secretion of melatonin (melatoninergic drugs (including antidepressants), beta-blockers)
- Refusal of participate
- Minor or major protected subject
- Not affiliated to a social security scheme
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 |
|---|---|---|
| melatonin and cortisol samplingThe study will take place over 15 days during which the nurses will wear an actigraphic wristband and will fulfill a sleep log. During 3 periods of 24 hours selected during these 15 days, including a 12h day shift (Day 2), a 12h night shift (Day 8) and a rest (Day 13), the participants will collect their urine by 4 to 8 hour periods, note the corresponding urine volumes and for each period, sample a 5 mL tube which will be analyzed later (6-sulfatoxymelatonin and urinary cortisol assays). The subjects will complete questionnaires at the beginning of the study (Horne and Ostberg, Insomnia Severity Index, Epworth, Pichot, Hospital Anxiety and Depression) and the days corresponding to the urine sampling (Karolinska and St Mary Hospital). | Other | melatonin and cortisol sampling |
Primary outcome
total amount of melatonin excreted during the sleep period for the night shift
Time frame: at day 8 (night shift)
The impact of 12H shift work on melatonin secretion dynamics will be assessed by comparing the total amount of melatonin excreted during the sleep period between the 12h day shift condition and the 12h night shift condition
total amount of melatonin excreted during the sleep period for the day shift.
Time frame: at day 2 (day shift)
The impact of 12H shift work on melatonin secretion dynamics will be assessed by comparing the total amount of melatonin excreted during the sleep period between the 12h day shift condition and the 12h night shift condition
43 secondary outcomes
Total amount of melatonin excreted during the sleep period at rest
Time frame: at day 13 (rest)
Melatonin secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Melatonin secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Melatonin secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Melatonin secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Melatonin secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Melatonin secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Melatonin secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Melatonin secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Melatonin secretion dynamics at rest
Time frame: at day 13 (rest)
Melatonin secretion dynamics at rest
Time frame: at day 13 (rest)
Melatonin secretion dynamics at rest
Time frame: at day 13 (rest)
Melatonin secretion dynamics at rest
Time frame: at day 13 (rest)
Cortisol secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Cortisol secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Cortisol secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Cortisol secretion dynamics in 12h day shift
Time frame: at day 2 (day shift)
Cortisol secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Cortisol secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Cortisol secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Cortisol secretion dynamics in 12h night shift
Time frame: at day 8 (night shift)
Cortisol secretion dynamics at rest
Time frame: at day 13 (rest)
Cortisol secretion dynamics at rest
Time frame: at day 13 (rest)
Cortisol secretion dynamics at rest
Time frame: at day 13 (rest)
Cortisol secretion dynamics at rest
Time frame: at day 13 (rest)
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep quality
Time frame: 15 days
Objective sleep duration
Time frame: 15 days
Excessive daytime sleepiness
Time frame: at day 1
Asthenia
Time frame: at day 1
Insomnia severity
Time frame: at day 1
Anxiety
Time frame: at day 1
Depression
Time frame: at day 1
Vigilance at awakening
Time frame: at day 2, 8 and 13
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 12 Feb 2018.
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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.
Laure Peter Derex, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melatonin and cortisol sampling in people with Shift-Work Sleep Disorder, run by Hospices Civils de Lyon 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 2 inclusion and 6 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 12 Feb 2018. 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?
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?
total amount of melatonin excreted during the sleep period for the night shift (time frame: at day 8 (night shift)). The study lists 2 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 12 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.