Biological Rhythms Impact of 12 Hours Shift Work

Shift-Work Sleep Disorder Clinical Trial

— MELACTI-12  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153917
• Other study ID #: 69HCL16_0624
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: February 9, 2018
• Start date: June 2, 2017
• Est. completion date: July 28, 2017

Study information

• Verified date: April 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parasomnias
• Shift-Work Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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).

Locations

Country	Name	City	State
France	Croix-Rousse Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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