NCT03859882

Brief Summary

In this multicentric controlled study, we aims to evaluate effect of caffeine on mental performances during a sleep deprivation protocol. Genetic polymorphisms are considered as a covariable.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1 day

First QC Date

February 25, 2019

Last Update Submit

August 25, 2021

Conditions

SleepCaffeinePolymorphism

Keywords

sleep deprivationcognitionattention

Outcome Measures

Primary Outcomes (1)

  • Psychomotor vigilance test Speed

    Speed at the Psychomotor vigilance test test

    Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking

Secondary Outcomes (2)

  • Cognitive performance

    Change from Baseline at day 2 after 25 hours awaking

  • Force -velocity

    Change from Baseline at day 2 after 32 hours awaking

Study Arms (2)

Caffeine

EXPERIMENTAL

Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day

Other: Sleep deprivation

placebo

PLACEBO COMPARATOR

in 2 administration (08:00 and 14:00) per day

Other: Sleep deprivation

Interventions

Sleep deprivationOTHER

40 hours of continuous awaking in the sleep laboratory in order to compare before and after sleep deprivation for each treatment (Caffeine vs. placebo).

Caffeineplacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subject

You may not qualify if:

  • Treatment
  • History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
  • Nonvoluntary
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de recherche biomedical des armées

Brétigny-sur-Orge, France

Location

Hotel Dieu

Paris, 75004, France

Location

Related Publications (5)

  • de Lorgeril B, Tardo-Dino PE, Bourrilhon C, Quiquempoix M, Drogou C, Mateo L, Erblang M, Colin P, Van Beers P, Chennaoui M, Gomez-Merino D, Sauvet F. Impact of acute caffeine intake on local tolerance to cold before and after total sleep deprivation. Exp Physiol. 2025 Sep;110(9):1254-1270. doi: 10.1113/EP092356. Epub 2025 Mar 27.

    PMID: 40150834DERIVED

  • Pauchon B, Beauchamps V, Gomez-Merino D, Erblang M, Drogou C, Beers PV, Guillard M, Quiquempoix M, Leger D, Chennaoui M, Sauvet F. Caffeine Intake Alters Recovery Sleep after Sleep Deprivation. Nutrients. 2024 Oct 11;16(20):3442. doi: 10.3390/nu16203442.

    PMID: 39458438DERIVED

  • Drogou C, Sauvet F, Erblang M, Leger D, Thomas C, Chennaoui M, Gomez-Merino D; Investigators group. Effects of Acute Caffeine Intake on Insulin-Like Growth Factor-1 Responses to Total Sleep Deprivation: Interactions with COMT Polymorphism - A Randomized, Crossover Study. Lifestyle Genom. 2023;16(1):113-123. doi: 10.1159/000529897. Epub 2023 Jun 6.

    PMID: 37279709DERIVED

  • Erblang M, Drogou C, Gomez-Merino D, Rabat A, Guillard M, Beers PV, Quiquempoix M, Boland A, Deleuze JF, Olaso R, Derbois C, Prost M, Dorey R, Leger D, Thomas C, Chennaoui M, Sauvet F. Genetics and Cognitive Vulnerability to Sleep Deprivation in Healthy Subjects: Interaction of ADORA2A, TNF-alpha and COMT Polymorphisms. Life (Basel). 2021 Oct 19;11(10):1110. doi: 10.3390/life11101110.

    PMID: 34685481DERIVED

  • Erblang M, Sauvet F, Drogou C, Quiquempoix M, Van Beers P, Guillard M, Rabat A, Trignol A, Bourrilhon C, Erkel MC, Leger D, Thomas C, Gomez-Merino D, Chennaoui M. Genetic Determinants of Neurobehavioral Responses to Caffeine Administration during Sleep Deprivation: A Randomized, Cross Over Study (NCT03859882). Genes (Basel). 2021 Apr 10;12(4):555. doi: 10.3390/genes12040555.

    PMID: 33920292DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 1, 2019

Study Start

September 2, 2018

Primary Completion

September 3, 2018

Study Completion

June 26, 2019

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)