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

Primary Purpose

Shift-Work Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
melatonin and cortisol sampling
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shift-Work Sleep Disorder focused on measuring shift work, melatonin, sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Croix-Rousse Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

melatonin and cortisol sampling

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Melatonin secretion dynamics in 12h day shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
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)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Melatonin secretion dynamics in 12h night shift
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Melatonin secretion dynamics at rest
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
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)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Cortisol secretion dynamics in 12h day shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
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)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Cortisol secretion dynamics in 12h night shift
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Cortisol secretion dynamics at rest
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Objective sleep quality
Measure of sleep latency assessed by sleep log
Objective sleep quality
Measure of sleep latency assessed by actigraphy
Objective sleep quality
Measure of sleep efficiency = total sleep / bedtime assessed by sleep log
Objective sleep quality
Measure of sleep efficiency = total sleep / bedtime assessed by actigraphy
Objective sleep quality
Measure of fragmentation index assessed by sleep log
Objective sleep quality
Measure of fragmentation index assessed by actigraphy
Objective sleep quality
Measure of intra-sleep wakefulness assessed by sleep log
Objective sleep quality
Measure of intra-sleep wakefulness assessed by actigraphy
Objective sleep duration
duration of sleep assessed by actigraphy
Excessive daytime sleepiness
This outcome will be assessed by the Epworth sleepiness Scale
Asthenia
This outcome will be assessed by the Pichot asthenia scale
Insomnia severity
This outcome will be assessed by the Insomnia Severity Index
Anxiety
This outcome will be assessed by the Hospital Anxiety and Depression scale
Depression
This outcome will be assessed by the Hospital Anxiety and Depression scale
Vigilance at awakening
This outcome will be assessed by the Karolinska scale
Sleep subjective quality
This outcome will be assessed by the St Mary Hospital Questionary
Chronotype
This outcome will be assessed by the Horne and Ostberg Questionary
Light exposition
This outcome will be assessed by the actigraphy

Full Information

First Posted
April 20, 2017
Last Updated
February 9, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03153917
Brief Title
Biological Rhythms Impact of 12 Hours Shift Work
Acronym
MELACTI-12
Official Title
Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder
Keywords
shift work, melatonin, sleep

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
melatonin and cortisol sampling
Arm Type
Experimental
Arm Description
14 healthy volunteer nurses working on 12 hours night/day schedules in the Sleep Medicine Center of Lyon.
Intervention Type
Other
Intervention Name(s)
melatonin and cortisol sampling
Intervention Description
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 Outcome Measure Information:
Title
total amount of melatonin excreted during the sleep period for the night shift
Description
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
Time Frame
at day 8 (night shift)
Title
total amount of melatonin excreted during the sleep period for the day shift.
Description
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
Time Frame
at day 2 (day shift)
Secondary Outcome Measure Information:
Title
Total amount of melatonin excreted during the sleep period at rest
Description
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
Time Frame
at day 13 (rest)
Title
Melatonin secretion dynamics in 12h day shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Time Frame
at day 2 (day shift)
Title
Melatonin secretion dynamics in 12h day shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Time Frame
at day 2 (day shift)
Title
Melatonin secretion dynamics in 12h day shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Time Frame
at day 2 (day shift)
Title
Melatonin secretion dynamics in 12h day shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Time Frame
at day 2 (day shift)
Title
Melatonin secretion dynamics in 12h night shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Time Frame
at day 8 (night shift)
Title
Melatonin secretion dynamics in 12h night shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Time Frame
at day 8 (night shift)
Title
Melatonin secretion dynamics in 12h night shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Time Frame
at day 8 (night shift)
Title
Melatonin secretion dynamics in 12h night shift
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Time Frame
at day 8 (night shift)
Title
Melatonin secretion dynamics at rest
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Time Frame
at day 13 (rest)
Title
Melatonin secretion dynamics at rest
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Time Frame
at day 13 (rest)
Title
Melatonin secretion dynamics at rest
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Time Frame
at day 13 (rest)
Title
Melatonin secretion dynamics at rest
Description
Secretion of melatonin on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Time Frame
at day 13 (rest)
Title
Cortisol secretion dynamics in 12h day shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Time Frame
at day 2 (day shift)
Title
Cortisol secretion dynamics in 12h day shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Time Frame
at day 2 (day shift)
Title
Cortisol secretion dynamics in 12h day shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Time Frame
at day 2 (day shift)
Title
Cortisol secretion dynamics in 12h day shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Time Frame
at day 2 (day shift)
Title
Cortisol secretion dynamics in 12h night shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Time Frame
at day 8 (night shift)
Title
Cortisol secretion dynamics in 12h night shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Time Frame
at day 8 (night shift)
Title
Cortisol secretion dynamics in 12h night shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Time Frame
at day 8 (night shift)
Title
Cortisol secretion dynamics in 12h night shift
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Time Frame
at day 8 (night shift)
Title
Cortisol secretion dynamics at rest
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of total excretion (ng)
Time Frame
at day 13 (rest)
Title
Cortisol secretion dynamics at rest
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of acrophase (h)
Time Frame
at day 13 (rest)
Title
Cortisol secretion dynamics at rest
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of amplitude (ng)
Time Frame
at day 13 (rest)
Title
Cortisol secretion dynamics at rest
Description
Secretion of cortisol on sequential urinary specimens collected every 4 or 8 hours. Measure of mesor (ng)
Time Frame
at day 13 (rest)
Title
Objective sleep quality
Description
Measure of sleep latency assessed by sleep log
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of sleep latency assessed by actigraphy
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of sleep efficiency = total sleep / bedtime assessed by sleep log
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of sleep efficiency = total sleep / bedtime assessed by actigraphy
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of fragmentation index assessed by sleep log
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of fragmentation index assessed by actigraphy
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of intra-sleep wakefulness assessed by sleep log
Time Frame
15 days
Title
Objective sleep quality
Description
Measure of intra-sleep wakefulness assessed by actigraphy
Time Frame
15 days
Title
Objective sleep duration
Description
duration of sleep assessed by actigraphy
Time Frame
15 days
Title
Excessive daytime sleepiness
Description
This outcome will be assessed by the Epworth sleepiness Scale
Time Frame
at day 1
Title
Asthenia
Description
This outcome will be assessed by the Pichot asthenia scale
Time Frame
at day 1
Title
Insomnia severity
Description
This outcome will be assessed by the Insomnia Severity Index
Time Frame
at day 1
Title
Anxiety
Description
This outcome will be assessed by the Hospital Anxiety and Depression scale
Time Frame
at day 1
Title
Depression
Description
This outcome will be assessed by the Hospital Anxiety and Depression scale
Time Frame
at day 1
Title
Vigilance at awakening
Description
This outcome will be assessed by the Karolinska scale
Time Frame
at day 2, 8 and 13
Title
Sleep subjective quality
Description
This outcome will be assessed by the St Mary Hospital Questionary
Time Frame
at day 2, 8 and 13
Title
Chronotype
Description
This outcome will be assessed by the Horne and Ostberg Questionary
Time Frame
at day 1
Title
Light exposition
Description
This outcome will be assessed by the actigraphy
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Peter Derex, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croix-Rousse Hospital
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Learn more about this trial

Biological Rhythms Impact of 12 Hours Shift Work

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