Skip to main content
OpenTrials
Completed

NCT Number: NCT03153917

Biological Rhythms Impact of 12 Hours Shift Work

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shift-Work Sleep Disorder Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Croix-Rousse Hospital

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

melatonin and cortisol sampling

Other

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).

Primary outcomes

  1. 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

  2. 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

  1. Total amount of melatonin excreted during the sleep period at rest

    Time frame: at 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

  2. Melatonin secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of total excretion (ng)

  3. Melatonin secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of acrophase (h)

  4. Melatonin secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of amplitude (ng)

  5. Melatonin secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of mesor (ng)

  6. Melatonin secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of total excretion (ng)

  7. Melatonin secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of acrophase (h)

  8. Melatonin secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of amplitude (ng)

  9. Melatonin secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of mesor (ng)

  10. Melatonin secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of total excretion (ng)

  11. Melatonin secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of acrophase (h)

  12. Melatonin secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of amplitude (ng)

  13. Melatonin secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours.

    Measure of mesor (ng)

  14. Cortisol secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of total excretion (ng)

  15. Cortisol secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of acrophase (h)

  16. Cortisol secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of amplitude (ng)

  17. Cortisol secretion dynamics in 12h day shift

    Time frame: at day 2 (day shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of mesor (ng)

  18. Cortisol secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of total excretion (ng)

  19. Cortisol secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of acrophase (h)

  20. Cortisol secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of amplitude (ng)

  21. Cortisol secretion dynamics in 12h night shift

    Time frame: at day 8 (night shift)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of mesor (ng)

  22. Cortisol secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of total excretion (ng)

  23. Cortisol secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of acrophase (h)

  24. Cortisol secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of amplitude (ng)

  25. Cortisol secretion dynamics at rest

    Time frame: at day 13 (rest)

    Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours.

    Measure of mesor (ng)

  26. Objective sleep quality

    Time frame: 15 days

    Measure of sleep latency assessed by sleep log

  27. Objective sleep quality

    Time frame: 15 days

    Measure of sleep latency assessed by actigraphy

  28. Objective sleep quality

    Time frame: 15 days

    Measure of sleep efficiency

    = total sleep / bedtime assessed by sleep log

  29. Objective sleep quality

    Time frame: 15 days

    Measure of sleep efficiency

    = total sleep / bedtime assessed by actigraphy

  30. Objective sleep quality

    Time frame: 15 days

    Measure of fragmentation index assessed by sleep log

  31. Objective sleep quality

    Time frame: 15 days

    Measure of fragmentation index assessed by actigraphy

  32. Objective sleep quality

    Time frame: 15 days

    Measure of intra-sleep wakefulness assessed by sleep log

  33. Objective sleep quality

    Time frame: 15 days

    Measure of intra-sleep wakefulness assessed by actigraphy

  34. Objective sleep duration

    Time frame: 15 days

    duration of sleep assessed by actigraphy

  35. Excessive daytime sleepiness

    Time frame: at day 1

    This outcome will be assessed by the Epworth sleepiness Scale

  36. Asthenia

    Time frame: at day 1

    This outcome will be assessed by the Pichot asthenia scale

  37. Insomnia severity

    Time frame: at day 1

    This outcome will be assessed by the Insomnia Severity Index

  38. Anxiety

    Time frame: at day 1

    This outcome will be assessed by the Hospital Anxiety and Depression scale

  39. Depression

    Time frame: at day 1

    This outcome will be assessed by the Hospital Anxiety and Depression scale

  40. Vigilance at awakening

    Time frame: at day 2, 8 and 13

    This outcome will be assessed by the Karolinska scale

  41. Sleep subjective quality

    Time frame: at day 2, 8 and 13

    This outcome will be assessed by the St Mary Hospital Questionary

  42. Chronotype

    Time frame: at day 1

    This outcome will be assessed by the Horne and Ostberg Questionary

  43. Light exposition

    Time frame: 15 days

    This outcome will be assessed by the actigraphy

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MELACTI-12

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 15, 2017
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.