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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
  Purpose

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.


Condition Intervention
Healthy Volunteers
 Other: sleep deprivation
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Sleep Deprivation on Driving Performance and Central Fatigue

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 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 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.

 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no smoking and drugs
  • regular physical activity

Exclusion Criteria:

  • insufficiency cardiac or respiratory
  • carrying a cardiac pacemaker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606020

Locations
France
CHU de Saint-Etienne
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Study Chair: Guillaume MILLET, PhD Université Jean Monnet - Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01606020     History of Changes
Other Study ID Numbers: 1108128, 2011-A00895-36
Study First Received: May 3, 2012
Last Updated: August 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
effects of sleep deprivation
Transcranial Magnetic Stimulation
male, healthy volunteers

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
 Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013