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Clinical Trials/NCT03153917
NCT03153917CompletedNot Applicable

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

Hospices Civils de Lyon1 site in 1 country15 target enrollmentStarted: June 2, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
total amount of melatonin excreted during the sleep period for the night shift

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

melatonin and cortisol sampling

Experimental

14 healthy volunteer nurses working on 12 hours night/day schedules in the Sleep Medicine Center of Lyon.

Intervention: melatonin and cortisol sampling (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Cortisol secretion dynamics in 12h day shift(at day 2 (day shift))
  • Cortisol secretion dynamics in 12h night shift(at day 8 (night shift))
  • Cortisol secretion dynamics at rest(at day 13 (rest))
  • Objective sleep quality(15 days)
  • Melatonin secretion dynamics in 12h day shift(at day 2 (day shift))
  • Melatonin secretion dynamics in 12h night shift(at day 8 (night shift))
  • Melatonin secretion dynamics at rest(at day 13 (rest))
  • Insomnia severity(at day 1)
  • Chronotype(at day 1)
  • Sleep subjective quality(at day 2, 8 and 13)
  • Light exposition(15 days)
  • Total amount of melatonin excreted during the sleep period at rest(at day 13 (rest))
  • Asthenia(at day 1)
  • Objective sleep duration(15 days)
  • Excessive daytime sleepiness(at day 1)
  • Anxiety(at day 1)
  • Depression(at day 1)
  • Vigilance at awakening(at day 2, 8 and 13)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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