SleepPERCAFNCT03859882
Protocol PERCAF 2018
A study testing Sleep deprivation in people with Sleep and Caffeine, run by Institut de Recherche Biomedicale des Armees at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Caffeine, Polymorphism
- What is being tested?
- Sleep deprivation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Sep 2018to 26 Jun 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subject
Who cannot join
- Treatment
- History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
- Nonvoluntary
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut de recherche biomedical des armées
Brétigny-sur-Orge
Hotel Dieu
Paris, 75004
About this study
Official title: Polymorphisms and Efficiency of Caffeine on Performances During Total Sleep Deprivation un Healthy Subject. Multicentric, Versus Placebo, Randomised, Cross Over, Double Blind Study
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.
Read the detailed description
Coffee is the most consumed arousing substance in the world. Caffeine is used as a natural countermeasure to maintain the performance of sleep deprived subjects. However, the effectiveness of caffeine is characterized by a large individual variability, also observed on side effects. This variability could notably be related to polymorphisms of the adenosine receptor 2a gene (ADORA2A) and Tumor Necrosis Factor-alpha, a pro-inflammatory cytokine whose increase is observed during sleep deprivation.
This study, under conditions of total sleep deprivation in the laboratory (40 hours of continuous awakening), examine the cross-influence of two polymorphisms (ADORA2A: rs5751876 and TNF-alpha: rs1800629) on the sensitivity to caffeine and on the degradation of attentional performances. Physical performance, mental performance, immuno-inflammatory responses and the occurrence indesirable effects will be evaluate.
This work aims to understand the mechanisms that contribute to increasing individual vulnerability and promoting protective countermeasures. The purpose of this project is to improve the recommendations concerning the daily use of caffeine and during periods of prolonged awakening, particularly in the military environment.
- Conditions
- Sleep, Caffeine, Polymorphism
- Being tested
- Sleep deprivation
- Keywords
- sleep deprivation, cognition, attention
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Caffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day Receives: Other: Sleep deprivation |
| placebo | Placebo comparator | in 2 administration (08:00 and 14:00) per day Receives: Other: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor vigilance test Speed
Speed at the Psychomotor vigilance test test
Measured: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking
Secondary outcomes (2)
Cognitive performance
Number of errors at executive performance test
Measured: Change from Baseline at day 2 after 25 hours awaking
Force -velocity
Power at the force-velocity test
Measured: Change from Baseline at day 2 after 32 hours awaking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start2 Sep 2018
- Primary completion3 Sep 2018
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 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
- NCT03859882
- Sponsor's protocol ID
- Protocol PERCAF 2018
- Acronym
- PERCAF
- Status last verified
- Aug 2021
- First submitted
- 25 Feb 2019
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mateo L, Tardo-Dino PE, Gomez-Merino D, Drogou C, Josse PE, Erblang M, Colin P, Erkel MC, Van Beers P, Leger D, Bourrilhon C, Chennaoui M, Sauvet F. Both acute and chronic caffeine consumption affect cardiovascular responses to total sleep deprivation. Front Cardiovasc Med. 2026 Jan 30;13:1718154. doi: 10.3389/fcvm.2026.1718154. eCollection 2026.
PubMed 41694313de 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.
PubMed 40150834Pauchon 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.
PubMed 39458438Drogou 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.
PubMed 37279709Erblang 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.
PubMed 34685481Erblang 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.
PubMed 33920292
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms and Efficiency of Caffeine on Performances During Total Sleep Deprivation un Healthy Subject. Multicentric, Versus Placebo, Randomised, Cross Over, Double Blind Study
- ClinicalTrials.gov ID
- NCT03859882
- Acronym / sponsor ID
- PERCAF / Protocol PERCAF 2018
- Conditions
- Sleep, Caffeine, Polymorphism
- Keywords
- sleep deprivation, cognition, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 1 Mar 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.
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.
Detailed description
Coffee is the most consumed arousing substance in the world. Caffeine is used as a natural countermeasure to maintain the performance of sleep deprived subjects. However, the effectiveness of caffeine is characterized by a large individual variability, also observed on side effects. This variability could notably be related to polymorphisms of the adenosine receptor 2a gene (ADORA2A) and Tumor Necrosis Factor-alpha, a pro-inflammatory cytokine whose increase is observed during sleep deprivation.
This study, under conditions of total sleep deprivation in the laboratory (40 hours of continuous awakening), examine the cross-influence of two polymorphisms (ADORA2A: rs5751876 and TNF-alpha: rs1800629) on the sensitivity to caffeine and on the degradation of attentional performances. Physical performance, mental performance, immuno-inflammatory responses and the occurrence indesirable effects will be evaluate.
This work aims to understand the mechanisms that contribute to increasing individual vulnerability and promoting protective countermeasures. The purpose of this project is to improve the recommendations concerning the daily use of caffeine and during periods of prolonged awakening, particularly in the military environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Other: Sleep deprivationCaffeine 5 mg/kg/day in 2 administration (08:00 and 14:00) per day |
| placebo | Placebo comparator | Other: Sleep deprivationin 2 administration (08:00 and 14:00) per day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subject
Key exclusion criteria (4 listed)
- Treatment
- History of cardiovascular, psychiatric, pneumologic, haematologic, cancerology disease
- Nonvoluntary
- Pregnancy
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 |
|---|---|---|
| Sleep deprivation40 hours of continuous awaking in the sleep laboratory in order to compare before and after sleep deprivation for each treatment (Caffeine vs. placebo). | Other | Caffeine, placebo |
Primary outcome
Psychomotor vigilance test Speed
Time frame: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking
Speed at the Psychomotor vigilance test test
2 secondary outcomes
Cognitive performance
Time frame: Change from Baseline at day 2 after 25 hours awaking
Force -velocity
Time frame: Change from Baseline at day 2 after 32 hours awaking
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 27 Aug 2021.
- Derived from this study: PubMed 41694313Mateo L, Tardo-Dino PE, Gomez-Merino D, Drogou C, Josse PE, Erblang M, Colin P, Erkel MC, Van Beers P, Leger D, Bourrilhon C, Chennaoui M, Sauvet F. Both acute and chronic caffeine consumption affect cardiovascular responses to total sleep deprivation. Front Cardiovasc Med. 2026 Jan 30;13:1718154. doi: 10.3389/fcvm.2026.1718154. eCollection 2026.
- Derived from this study: PubMed 40150834de 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.
- Derived from this study: PubMed 39458438Pauchon 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.
- Derived from this study: PubMed 37279709Drogou 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.
- Derived from this study: PubMed 34685481Erblang 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.
- Derived from this study: PubMed 33920292Erblang 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.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Sleep and Caffeine, run by Institut de Recherche Biomedicale des Armees at 2 sites 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 4 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Psychomotor vigilance test Speed (time frame: Change from Baseline Psychomotor vigilance test Speed at day 2 after 24 hours awaking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859882, which also lists 6 linked publications.
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 27 Aug 2021.