Sleep Deprivation : Effects on Driving Performance and Central Fatigue (PrivSom)
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ClinicalTrials.gov Identifier: NCT01606020 |
Recruitment Status
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Completed
First Posted
: May 25, 2012
Last Update Posted
: August 22, 2012
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Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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
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Change History | Complete list of historical versions of study NCT01606020 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Healthy Volunteers | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 |
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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 |