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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01606020
First received: May 3, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes

May 3, 2012
August 21, 2012
September 2011
July 2012   (final data collection date for primary outcome measure)
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal [ Time Frame: at Day 7 and Day 28 ] [ Designated as safety issue: No ]
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 value of the level of maximal voluntary activation of quadriceps muscle supraspinal [ Time Frame: at D7 and D28 ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01606020 on ClinicalTrials.gov Archive Site
  • variation of the activation level of excitability and supraspinal / cortical [ Time Frame: At Day 7 and Day 28 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation
  • variation of the activation level of excitability and supraspinal / cortical [ Time Frame: At D7 and D28 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation
Not Provided
Not Provided
 
Sleep Deprivation : Effects on Driving Performance and Central Fatigue
Effects of Sleep Deprivation on Driving Performance and Central Fatigue
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • no smoking and drugs
  • regular physical activity

Exclusion Criteria:

  • insufficiency cardiac or respiratory
  • carrying a cardiac pacemaker
Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01606020
1108128, 2011-A00895-36
No
Not Provided
Not Provided
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Study Chair: Guillaume MILLET, PhD Université Jean Monnet - Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP