Clinical trial NCT03153917: Biological Rhythms Impact of 12 Hours Shift Work
Official title: Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Sleep Disorder
Keywords: shift work
melatonin
sleep
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: total amount of melatonin excreted during the sleep period for the night shift
timeFrame: at day 8 (night shift)
measure: total amount of melatonin excreted during the sleep period for the day shift.
timeFrame: at day 2 (day shift)
Secondary outcomes:
measure: Total amount of melatonin excreted during the sleep period at rest
timeFrame: at day 13 (rest)
measure: Melatonin secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Melatonin secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Melatonin secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Melatonin secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Melatonin secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Melatonin secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Melatonin secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Melatonin secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Melatonin secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Melatonin secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Melatonin secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Melatonin secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Cortisol secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Cortisol secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Cortisol secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Cortisol secretion dynamics in 12h day shift
timeFrame: at day 2 (day shift)
measure: Cortisol secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Cortisol secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Cortisol secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Cortisol secretion dynamics in 12h night shift
timeFrame: at day 8 (night shift)
measure: Cortisol secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Cortisol secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Cortisol secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Cortisol secretion dynamics at rest
timeFrame: at day 13 (rest)
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep quality
timeFrame: 15 days
measure: Objective sleep duration
timeFrame: 15 days
measure: Excessive daytime sleepiness
timeFrame: at day 1
measure: Asthenia
timeFrame: at day 1
measure: Insomnia severity
timeFrame: at day 1
measure: Anxiety
timeFrame: at day 1
measure: Depression
timeFrame: at day 1
measure: Vigilance at awakening
timeFrame: at day 2, 8 and 13
measure: Sleep subjective quality
timeFrame: at day 2, 8 and 13
measure: Chronotype
timeFrame: at day 1
measure: Light exposition
timeFrame: 15 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Laure Peter Derex, MD
role: PRINCIPAL_INVESTIGATOR
References: