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Biological Rhythms Impact of 12 Hours Shift Work

Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03153917
Acronym
MELACTI-12
Enrollment
15
Registered
2017-05-15
Start date
2017-06-02
Completion date
2017-07-28
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shift-Work Sleep Disorder

Keywords

shift work, melatonin, sleep

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.

Interventions

OTHERmelatonin and cortisol sampling

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).

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
total amount of melatonin excreted during the sleep period for the night shiftat 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.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

Secondary

MeasureTime frameDescription
Melatonin secretion dynamics in 12h night shiftat day 8 (night shift)Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Melatonin secretion dynamics at restat day 13 (rest)Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Cortisol secretion dynamics in 12h day shiftat day 2 (day shift)Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Cortisol secretion dynamics in 12h night shiftat day 8 (night shift)Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Cortisol secretion dynamics at restat day 13 (rest)Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Objective sleep quality15 daysMeasure of sleep latency assessed by sleep log
Objective sleep duration15 daysduration of sleep assessed by actigraphy
Excessive daytime sleepinessat day 1This outcome will be assessed by the Epworth sleepiness Scale
Total amount of melatonin excreted during the sleep period at restat day 13 (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
Insomnia severityat day 1This outcome will be assessed by the Insomnia Severity Index
Anxietyat day 1This outcome will be assessed by the Hospital Anxiety and Depression scale
Depressionat day 1This outcome will be assessed by the Hospital Anxiety and Depression scale
Vigilance at awakeningat day 2, 8 and 13This outcome will be assessed by the Karolinska scale
Sleep subjective qualityat day 2, 8 and 13This outcome will be assessed by the St Mary Hospital Questionary
Chronotypeat day 1This outcome will be assessed by the Horne and Ostberg Questionary
Light exposition15 daysThis outcome will be assessed by the actigraphy
Astheniaat day 1This outcome will be assessed by the Pichot asthenia scale
Melatonin secretion dynamics in 12h day shiftat day 2 (day shift)Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026