NCT01989741

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2013

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

January 12, 2013

Last Update Submit

November 20, 2013

Conditions

Keywords

sleep restriction, decision making, wakefullness

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

OTHER

Longitudinal study of response to sleep restriction. Comparison between baseline values and sleep restriction values

Other: Sleep restriction

Interventions

4 hours sleep by night during one week

sleep restriction

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Fabien SAUVET, MD, PhD

    Institut de recherche biomédicale des armées

    PRINCIPAL INVESTIGATOR

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

Locations