Biological Rhythms Impact of 12 Hours Shift Work

NCT ID: NCT03153917

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2017-07-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

melatonin and cortisol sampling

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

Group Type: EXPERIMENTAL

melatonin and cortisol sampling

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laure Peter Derex, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Croix-Rousse Hospital

Lyon, , France

Countries

France

Other Identifiers

69HCL16_0624

Identifier Type: -

Identifier Source: org_study_id