Effect of Sleep Restriction on Decision Making and Inflammation
1 other identifier
interventional
12
1 country
1
Brief Summary
- hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes
- inclusion criterias: healthy subjects, men, under 35 years, BMI\<26, no sleep troubles, intermediate chronotype
- design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).
- parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure
- control of sleep restriction: continuous polysomnographic survey
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
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 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 12, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedNovember 21, 2013
November 1, 2013
3 months
January 12, 2013
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
London tower test score (décision making)
% of good score and mean response time resulting from London Tower test, assessed during baseline, sleep restriction (day 1 to day 5) and recovery (day 1 to day 3) at 10 AM
up to 3 days
Secondary Outcomes (3)
wakefulness
maintenance of wakefulness test (MWT) score observed every day during baselline, sleep restriction and recovery at 09 AM, 12 AM, 4 PM and 7 PM
cognitive function
up to 3 days
Inflammation
biological marker of inflammation levels assessed every day during baseline, sleep restriction and recovery at 08 AM
Study Arms (1)
sleep restriction
OTHERLongitudinal study of response to sleep restriction. Comparison between baseline values and sleep restriction values
Interventions
Eligibility Criteria
You may qualify if:
- healthy men, \< 35 yr old, BMI\<26, intermediate chronotype
You may not qualify if:
- sleep trouble, acute or chronique disease (cardiological, neurological...), women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de recherche biomédicale des armées
Brétigny-sur-Orge, 91223, France
Related Publications (2)
Rabat A, Gomez-Merino D, Roca-Paixao L, Bougard C, Van Beers P, Dispersyn G, Guillard M, Bourrilhon C, Drogou C, Arnal PJ, Sauvet F, Leger D, Chennaoui M. Differential Kinetics in Alteration and Recovery of Cognitive Processes from a Chronic Sleep Restriction in Young Healthy Men. Front Behav Neurosci. 2016 May 23;10:95. doi: 10.3389/fnbeh.2016.00095. eCollection 2016.
PMID: 27242464DERIVEDSauvet F, Drogou C, Bougard C, Arnal PJ, Dispersyn G, Bourrilhon C, Rabat A, Van Beers P, Gomez-Merino D, Faraut B, Leger D, Chennaoui M. Vascular response to 1 week of sleep restriction in healthy subjects. A metabolic response? Int J Cardiol. 2015;190:246-55. doi: 10.1016/j.ijcard.2015.04.119. Epub 2015 Apr 16.
PMID: 25932797DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabien SAUVET, MD, PhD
Institut de recherche biomédicale des armées
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- médecin principal (MD, PhD)
Study Record Dates
First Submitted
January 12, 2013
First Posted
November 21, 2013
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 21, 2013
Record last verified: 2013-11