Biological Rhythms Impact of 12 Hours Shift Work (MELACTI-12)

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.

Study Overview

• Status: Completed
• Conditions: Shift-Work Sleep Disorder
• Intervention / Treatment: Other: melatonin and cortisol sampling

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Croix-Rousse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: melatonin and cortisol sampling; 14 healthy volunteer nurses working on 12 hours night/day schedules in the Sleep Medicine Center of Lyon.

Other: melatonin 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at day 2 (day shift)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	at day 13 (rest)
Objective sleep quality	Measure of sleep latency assessed by sleep log	15 days
Objective sleep quality	Measure of sleep latency assessed by actigraphy	15 days
Objective sleep quality	Measure of sleep efficiency = total sleep / bedtime assessed by sleep log	15 days
Objective sleep quality	Measure of sleep efficiency = total sleep / bedtime assessed by actigraphy	15 days
Objective sleep quality	Measure of fragmentation index assessed by sleep log	15 days
Objective sleep quality	Measure of fragmentation index assessed by actigraphy	15 days
Objective sleep quality	Measure of intra-sleep wakefulness assessed by sleep log	15 days
Objective sleep quality	Measure of intra-sleep wakefulness assessed by actigraphy	15 days
Objective sleep duration	duration of sleep assessed by actigraphy	15 days
Excessive daytime sleepiness	This outcome will be assessed by the Epworth sleepiness Scale	at day 1
Asthenia	This outcome will be assessed by the Pichot asthenia scale	at day 1
Insomnia severity	This outcome will be assessed by the Insomnia Severity Index	at day 1
Anxiety	This outcome will be assessed by the Hospital Anxiety and Depression scale	at day 1
Depression	This outcome will be assessed by the Hospital Anxiety and Depression scale	at day 1
Vigilance at awakening	This outcome will be assessed by the Karolinska scale	at day 2, 8 and 13
Sleep subjective quality	This outcome will be assessed by the St Mary Hospital Questionary	at day 2, 8 and 13
Chronotype	This outcome will be assessed by the Horne and Ostberg Questionary	at day 1
Light exposition	This outcome will be assessed by the actigraphy	15 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Laure Peter Derex, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: sleep; melatonin; shift work
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anti-Inflammatory Agents; Protective Agents; Antioxidants; Melatonin; Hydrocortisone
• Other Study ID Numbers: 69HCL16_0624

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No