PolymorphismSOCAFNCT03855774
Polymorphisms, Caffeine and Sleep Disorders
A study testing Polymorphisms in people with Polymorphism and Sleep Disorder, run by Institut de Recherche Biomedicale des Armees at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Polymorphism, Sleep Disorder, Coffee-Workers' Disease
- What is being tested?
- Polymorphisms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- active workers
Who cannot join
- inactive subject (unemployed, student...)
- involuntary subject
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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 ...
Read the 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?
- Conditions
- Polymorphism, Sleep Disorder, Coffee-Workers' Disease
- Being tested
- Polymorphisms
- Keywords
- healthy subject, epidemiological
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolymorphismsGenetic
Classification of sleep disorders using 22 genetic polymorphisms
| Study group | Role | What they receive |
|---|---|---|
| Polymorphisms | Other | Classification of sleep disorders prevalence through polymorphisms Receives: Genetic: Polymorphisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphisms and sleep disorders
Sleep disorders frequency by genetic polymorphism
Measured: 1 salivary sample (screening)
Secondary outcomes (1)
Sleep duration
Total sleep time (hours) in function of polymorphisms
Measured: 1 salivary sample (screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymorphismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Epidemiological and genetic screening of a population
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855774
- Sponsor's protocol ID
- PDH-1-SMO-2-0509-op1
- Other IDs
- IDRCB
- Acronym
- SOCAF
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms, Caffeine and Sleep Disorders
- ClinicalTrials.gov ID
- NCT03855774
- Acronym / sponsor ID
- SOCAF / PDH-1-SMO-2-0509-op1
- Conditions
- Polymorphism, Sleep Disorder, Coffee-Workers' Disease
- Keywords
- healthy subject, epidemiological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Epidemiological and genetic screening of a population
| Arm | Type | Receives |
|---|---|---|
| Polymorphisms | Other | Genetic: PolymorphismsClassification of sleep disorders prevalence through polymorphisms |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- active workers
Key exclusion criteria (2 listed)
- inactive subject (unemployed, student...)
- involuntary subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolymorphismsClassification of sleep disorders using 22 genetic polymorphisms | Genetic | Polymorphisms |
Primary outcome
Polymorphisms and sleep disorders
Time frame: 1 salivary sample (screening)
Sleep disorders frequency by genetic polymorphism
1 secondary outcome
Sleep duration
Time frame: 1 salivary sample (screening)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymorphisms in people with Polymorphism and Sleep Disorder, run by Institut de Recherche Biomedicale des Armees at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymorphisms and sleep disorders (time frame: 1 salivary sample (screening)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.