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OpenTrials
Completed

NCT Number: NCT01989741

Effect of Sleep Restriction on Decision Making and Inflammation

* 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

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institut de recherche biomédicale des armées

Brétigny-sur-Orge, 91223, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sleep Restriction

Other

4 hours sleep by night during one week

Primary outcomes

  1. London tower test score (décision making)

    Time frame: 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 outcomes

  1. 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

  2. cognitive function

    Time frame: up to 3 days

  3. Inflammation

    Time frame: biological marker of inflammation levels assessed every day during baseline, sleep restriction and recovery at 08 AM

Sponsors and collaborators

Lead sponsor

Institut de Recherche Biomedicale des Armees

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 21, 2013
Registry last updated
Nov 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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