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Polymorphisms, Caffeine and Sleep Disorders (SOCAF)

Primary Purpose

Polymorphism, Sleep Disorder, Coffee-Workers' Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polymorphisms
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Polymorphism focused on measuring healthy subject, epidemiological

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • active workers

Exclusion Criteria:

  • inactive subject (unemployed, student...)
  • involuntary subject

Sites / Locations

  • Fabien SAUVET

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Polymorphisms

Arm Description

Classification of sleep disorders prevalence through polymorphisms

Outcomes

Primary Outcome Measures

Polymorphisms and sleep disorders
Sleep disorders frequency by genetic polymorphism

Secondary Outcome Measures

Sleep duration
Total sleep time (hours) in function of polymorphisms

Full Information

First Posted
February 25, 2019
Last Updated
February 26, 2019
Sponsor
Institut de Recherche Biomedicale des Armees
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1. Study Identification

Unique Protocol Identification Number
NCT03855774
Brief Title
Polymorphisms, Caffeine and Sleep Disorders
Acronym
SOCAF
Official Title
Polymorphisms, Caffeine and Sleep Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherche Biomedicale des Armees

4. Oversight

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

5. Study Description

Brief Summary
Screening of a population of volunteer workers recruited on the occasion of their occupational health visit, within the Ministry of Defense and civil enterprises. The voluntary subjects included will, after signing a consent, take a saliva sample (Kit Oragen DNA OG500) and fill out a computerized questionnaire. A posteriori, the genotyping polymorphisms may be associated with variations in the pharmacokinetics or pharmacodynamics of caffeine will be achieved. The primary objective is to determine whether polymorphisms (alone or in combination) of genes associated with the pharmacokinetics or pharmacodynamics of caffeine are independent risk factors for sleep disorders. The secondary objectives are to determine the frequency of these polymorphisms and to evaluate the consequences of these associations on sleep habits (sleep time, chronotype, quality of sleep), daytime sleepiness, caffeine consumption, antecedents of accidents at work or traffic, drug consumption ...
Detailed Description
Coffee is one of the most consumed drinks in the world and its consumption has doubled in 20 years. Because of the health benefits of caffeine (present in many foods and medicines), but also adverse effects, its physiological actions deserve to be better known and its use better framed. Indeed, caffeine is the most used psychoactive substance to prevent the deterioration of the cognitive performance of night workers and soldiers in operation. Its "strategic" use is even recommended in many armies. In its sustained-release dosage form (Caffeine 300 mg), it is the only drug, increasing alertness, authorized in the French military. Caffeine also has beneficial effects on inflammatory response, muscle activity, insulin sensitivity, cardiovascular risk, weight gain, neuroprotection, chronic pain. Usual consumption of 2 to 3 coffees a day is recommended by the American Nutrition Society. However, coffee consumption is associated with many side effects such as anxiety, sleep disorders, increased blood pressure, cardiovascular and obstetric conditions or depression. Many authors therefore recommend limiting its use. In particular, it is considered a risk factor for sleep disorders such as insomnia. The physiological effects and sensitivity to side effects of caffeine are characterized by very high individual variability3 related to age, sex, habitual coffee consumption, smoking, but also to genetic polymorphisms. Indeed, multiple polymorphisms are associated with changes in pharmacokinetics (see Table 1) or pharmacodynamics (efficacy, see Table 2) of caffeine. Sensitivity to caffeine is associated in particular with greater vulnerability to sleep deprivation, sleep disorders and stress.n particular, polymorphisms of the adenosine receptor (ADORA) gene, a therapeutic target for caffeine, are particularly involved in the individual variability of caffeine sensitivity, side effects and consumption habits. But many other polymorphisms of genes encoding enzymes involved in metabolism or physiological effects are also associated with the individual variability of caffeine. On the other hand, some gene polymorphisms such as the adenosine deaminase gene (ADA) which degrades caffeine and regulates intra- and extracellular concentrations, are associated with greater vulnerability to sleep deprivation, without the effects on caffeine sensitivity are known. Currently, it is difficult to assess the impact of these polymorphisms on the beneficial effects and / or risks associated with caffeine consumption due to their number and lifestyle, including coffee consumption. In other words, are sleep disorders favored by polymorphism and / or habitual consumption of caffeine? Are there profiles of high vulnerability to sleep deprivation and sensitivity to caffeine? Do these polymorphisms have a link with burnout, work stress, diseases?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymorphism, Sleep Disorder, Coffee-Workers' Disease
Keywords
healthy subject, epidemiological

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Epidemiological and genetic screening of a population
Masking
None (Open Label)
Allocation
N/A
Enrollment
1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polymorphisms
Arm Type
Other
Arm Description
Classification of sleep disorders prevalence through polymorphisms
Intervention Type
Genetic
Intervention Name(s)
Polymorphisms
Intervention Description
Classification of sleep disorders using 22 genetic polymorphisms
Primary Outcome Measure Information:
Title
Polymorphisms and sleep disorders
Description
Sleep disorders frequency by genetic polymorphism
Time Frame
1 salivary sample (screening)
Secondary Outcome Measure Information:
Title
Sleep duration
Description
Total sleep time (hours) in function of polymorphisms
Time Frame
1 salivary sample (screening)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: active workers Exclusion Criteria: inactive subject (unemployed, student...) involuntary subject
Facility Information:
Facility Name
Fabien SAUVET
City
Bretigny sur Orge
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Polymorphisms, Caffeine and Sleep Disorders

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