Effect of Sleep Restriction on Decision Making and Inflammation

Not Applicable

Completed

• Conditions: Sleep Deprivation

• Registration Number: NCT01989741
• Lead Sponsor: Institut de Recherche Biomedicale des Armees

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-01-12
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• healthy men, < 35 yr old, BMI<26, intermediate chronotype

Exclusion Criteria

• sleep trouble, acute or chronique disease (cardiological, neurological...), women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
London tower test score (décision making)	up to 3 days	% 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

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de recherche biomédicale des armées; 🇫🇷 Brétigny sur Orge, France