Back to resultsEffect of Sleep Restriction on Decision Making and Inflammation
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleep restriction
Sponsored by
About this trial
This is an interventional health services research trial for Sleep Deprivation focused on measuring sleep restriction, decision making, wakefullness
Eligibility Criteria
Inclusion Criteria:
- healthy men, < 35 yr old, BMI<26, intermediate chronotype
Exclusion Criteria:
- sleep trouble, acute or chronique disease (cardiological, neurological...), women
Sites / Locations
- Institut de recherche biomédicale des armées
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
sleep restriction
Arm Description
Longitudinal study of response to sleep restriction. Comparison between baseline values and sleep restriction values
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
wakefulness
cognitive function
Inflammation
Full Information
NCT ID
NCT01989741
First Posted
January 12, 2013
Last Updated
November 20, 2013
Sponsor
Institut de Recherche Biomedicale des Armees
1. Study Identification
Unique Protocol Identification Number
NCT01989741
Brief Title
Effect of Sleep Restriction on Decision Making and Inflammation
Official Title
Effect of Sleep Restriction on Decision Making and Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche Biomedicale des Armees
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep restriction, decision making, wakefullness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sleep restriction
Arm Type
Other
Arm Description
Longitudinal study of response to sleep restriction. Comparison between baseline values and sleep restriction values
Intervention Type
Other
Intervention Name(s)
Sleep restriction
Intervention Description
4 hours sleep by night during one week
Primary Outcome Measure Information:
Title
London tower test score (décision making)
Description
% 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
Time Frame
up to 3 days
Secondary Outcome Measure Information:
Title
wakefulness
Time Frame
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
Title
cognitive function
Time Frame
up to 3 days
Title
Inflammation
Time Frame
biological marker of inflammation levels assessed every day during baseline, sleep restriction and recovery at 08 AM
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy men, < 35 yr old, BMI<26, intermediate chronotype
Exclusion Criteria:
sleep trouble, acute or chronique disease (cardiological, neurological...), women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien SAUVET, MD, PhD
Organizational Affiliation
Institut de recherche biomédicale des armées
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de recherche biomédicale des armées
City
Brétigny sur Orge
ZIP/Postal Code
91223
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27242464
Citation
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.
Results Reference
derived
PubMed Identifier
25932797
Citation
Sauvet 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.
Results Reference
derived
Learn more about this trial
Effect of Sleep Restriction on Decision Making and Inflammation
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