Polymorphisms, Caffeine and Sleep Disorders

NCT03855774 | Completed DMC

• 2 other identifiers: PDH-1-SMO-2-0509-op1IDRCB
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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 ...

Conditions

Polymorphism; Sleep Disorder; Coffee-Workers' Disease

Keywords

healthy subject; epidemiological

Outcome Measures

Primary Outcomes (1)

• Polymorphisms and sleep disorders

  Sleep disorders frequency by genetic polymorphism

  1 salivary sample (screening)

Secondary Outcomes (1)

• Sleep duration

  1 salivary sample (screening)

Study Arms (1)

Polymorphisms

OTHER

Classification of sleep disorders prevalence through polymorphisms

Genetic: Polymorphisms

Interventions

Polymorphisms GENETIC

Classification of sleep disorders using 22 genetic polymorphisms

Polymorphisms

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• active workers

You may not qualify if:

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

Sponsors & Collaborators

• Institut de Recherche Biomedicale des Armees: lead

Study Sites (1)

Fabien SAUVET

Brétigny-sur-Orge, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Polymorphism, Genetic

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Genetic Variation; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Epidemiological and genetic screening of a population

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 28, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)