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Clinical Trials/NCT01989741
NCT01989741CompletedNot Applicable

Effect of Sleep Restriction on Decision Making and Inflammation

Institut de Recherche Biomedicale des Armees2 sites in 1 country12 target enrollmentStarted: September 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
London tower test score (décision making)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Institut de Recherche Biomedicale des Armees
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

SAUVET Fabien

médecin principal (MD, PhD)

Institut de Recherche Biomedicale des Armees

Study Sites (2)

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