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

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sleep deprivation
No intervention
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers focused on measuring effects of sleep deprivation, Transcranial Magnetic Stimulation, male, healthy volunteers

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • no smoking and drugs
  • regular physical activity

Exclusion Criteria:

  • insufficiency cardiac or respiratory
  • carrying a cardiac pacemaker

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sleep deprivation First

sleep deprivation second

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

change value of the level of maximal voluntary activation of quadriceps muscle supraspinal
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
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
level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation

Full Information

First Posted
May 3, 2012
Last Updated
August 21, 2012
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT01606020
Brief Title
Sleep Deprivation : Effects on Driving Performance and Central Fatigue
Acronym
PrivSom
Official Title
Effects of Sleep Deprivation on Driving Performance and Central Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
effects of sleep deprivation, Transcranial Magnetic Stimulation, male, healthy volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep deprivation First
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sleep deprivation second
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
sleep deprivation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Overnight, the subjects stay in their homes. No intervention during this night
Primary Outcome Measure Information:
Title
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal
Description
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
Time Frame
at Day 7 and Day 28
Secondary Outcome Measure Information:
Title
variation of the activation level of excitability and supraspinal / cortical
Description
variation of the activation level of excitability and supraspinal / cortical inhibition after a night of sleep deprivation
Time Frame
At Day 7 and Day 28
Title
level variation in test performance from test of Simon
Description
level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation
Time Frame
At Day 7 and Day 28

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: no smoking and drugs regular physical activity Exclusion Criteria: insufficiency cardiac or respiratory carrying a cardiac pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume MILLET, PhD
Organizational Affiliation
Université Jean Monnet-Saint-Etienne
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

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Sleep Deprivation : Effects on Driving Performance and Central Fatigue

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