Biological Rhythms Impact of 12 Hours Shift Work

NCT03153917 | Completed

• 1 other identifier: 69HCL16_0624
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Shift-Work Sleep Disorder

Keywords

shift work; melatonin; sleep

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (43)

• Total amount of melatonin excreted during the sleep period at rest

  at day 13 (rest)

• Melatonin secretion dynamics in 12h day shift

  at day 2 (day shift)

• Melatonin secretion dynamics in 12h day shift

  at day 2 (day shift)

• Melatonin secretion dynamics in 12h day shift

  at day 2 (day shift)

• Melatonin secretion dynamics in 12h day shift

  at day 2 (day shift)

Study Arms (1)

melatonin and cortisol sampling

EXPERIMENTAL

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

Other: melatonin and cortisol sampling

Interventions

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).

melatonin and cortisol sampling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix-Rousse Hospital

Lyon, 69004, France

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Laure Peter Derex, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 15, 2017
• Study Start: June 2, 2017
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: February 12, 2018

Record last verified: 2017-04

Locations

FR (1)