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

• ClinicalTrials.gov Identifier: NCT01606020
• Recruitment Status: Completed
• First Posted: May 25, 2012
• Last Update Posted: August 22, 2012
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Tracking Information

• First Submitted Date: May 3, 2012
• First Posted Date: May 25, 2012
• Last Update Posted Date: August 22, 2012
• Study Start Date: September 2011
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sleep Deprivation : Effects on Driving Performance and Central Fatigue
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy Volunteers

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 23, 2012): 12
• Original Estimated Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01606020
• Other Study ID Numbers: 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: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Not Provided

Investigators

• Study Chair: Guillaume MILLET, PhD; Université Jean Monnet - Saint-Etienne

• PRS Account: Centre Hospitalier Universitaire de Saint Etienne
• Verification Date: August 2012