Sleep Deprivation : Effects on Driving Performance and Central Fatigue (PrivSom)

Tracking Information
First Submitted Date ICMJE	May 3, 2012
First Posted Date ICMJE	May 25, 2012
Last Update Posted Date	August 22, 2012
Study Start Date ICMJE	September 2011
Actual Primary Completion Date	July 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 25, 2012)	change value of the level of maximal voluntary activation of quadriceps muscle supraspinal [ Time Frame: at Day 7 and Day 28 ]; change value of the level of maximal voluntary activation of quadriceps muscle supraspinal between before and after endurance exercise after a night of sleep deprivation
Original Primary Outcome Measures ICMJE; (submitted: May 23, 2012)	change value of the level of maximal voluntary activation of quadriceps muscle supraspinal [ Time Frame: at D7 and D28 ]; change value of the level of maximal voluntary activation of quadriceps muscle supraspinal between before and after endurance exercise after a night of sleep deprivation
Change History	Complete list of historical versions of study NCT01606020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 25, 2012)	variation of the activation level of excitability and supraspinal / cortical [ Time Frame: At Day 7 and Day 28 ]variation of the activation level of excitability and supraspinal / cortical inhibition after a night of sleep deprivation; level variation in test performance from test of Simon [ Time Frame: At Day 7 and Day 28 ]level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation
Original Secondary Outcome Measures ICMJE; (submitted: May 23, 2012)	variation of the activation level of excitability and supraspinal / cortical [ Time Frame: At D7 and D28 ]variation of the activation level of excitability and supraspinal / cortical inhibition after a night of sleep deprivation; level variation in test performance from test of Simon [ Time Frame: At D7 and D28 ]level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Sleep Deprivation : Effects on Driving Performance and Central Fatigue
Official Title ICMJE	Effects of Sleep Deprivation on Driving Performance and Central Fatigue
Brief Summary	The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal versus prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD.
Detailed Description	The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal vs. prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD. However, the causes of this accentuated fatigability in endurance exercise with sleep deficit are not known. Several hypotheses have been proposed such as lower pH before exercise, lower ventilation due to depreciated response to hypercapnia/hypoxia, or haemodilution. Yet the most plausible explanation is a lower tolerance to prolonged exercise because SD increases the rate of perceived exertion. Another potential effect of SD is an alteration of central command during exercise. The literature is rather scarce on this topic and is only based on a few animal studies. In humans, no effect of SD on maximal strength has been reported so that maximal voluntary activation should in theory not be altered. Transcranial Magnetic Stimulation (TMS), that allows to induce a motor response from its cortical origin (and to measure the resulting contraction), is a promising tool to explore neuromuscular function. TMS has been used only in three studies after SD, none of them involving exercise and none of them measuring mechanical responses (i.e. only EMG responses, such as motor evoked potential, were measured). In addition, the results of these three studies are contradictory. The effects of SD on central fatigue (i.e. increase of the activation deficit during exercise) have never been investigated. The goal of this experiment is thus to test the hypothesis that an increase in central fatigue (at supraspinal level) in SD can participate to performance alteration during a prolonged exercise. For that purpose, measurements of neuromuscular function particularly dedicated to assess central fatigue will be performed before and after SD but also when combining SD and a fatiguing exercise conducted until exhaustion.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
Condition ICMJE	Healthy Volunteers
Intervention ICMJE	Other: sleep deprivation Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep.; Other: No intervention Overnight, the subjects stay in their homes. No intervention during this night
Study Arms	Active Comparator: Sleep deprivation First First night D7 : Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep. Second night D28 : Overnight, the subjects stay in their homes. No intervention during this night. Interventions: Other: sleep deprivation Other: No intervention; Active Comparator: sleep deprivation second First night D7 : Overnight, the subjects stay in their homes. No intervention during this night. Second night D28 : Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep. Interventions: Other: sleep deprivation Other: No intervention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 23, 2012)	12
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2012
Actual Primary Completion Date	July 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: no smoking and drugs; regular physical activity Exclusion Criteria: insufficiency cardiac or respiratory; carrying a cardiac pacemaker
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01606020
Other Study ID Numbers ICMJE	1108128; 2011-A00895-36 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor ICMJE	Centre Hospitalier Universitaire de Saint Etienne
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Guillaume MILLET, PhD Université Jean Monnet - Saint-Etienne
PRS Account	Centre Hospitalier Universitaire de Saint Etienne
Verification Date	August 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP