Ignite Creation Date:
2024-05-06 @ 12:48 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03855774
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2019-02-25
Brief Title:
Polymorphisms Caffeine and Sleep Disorders
Sponsor:
Institut de Recherche Biomedicale des Armees
Organization:
Institut de Recherche Biomedicale des Armees
Study Overview
Official Title:
Polymorphisms Caffeine and Sleep Disorders
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOCAF
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
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 stressn 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
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 stressn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB | OTHER | 017-A00234-49 | None |