- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01606020
Sleep Deprivation : Effects on Driving Performance and Central Fatigue (PrivSom)
Effects of Sleep Deprivation on Driving Performance and Central Fatigue
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint-etienne, France, 42000
- CHU de Saint-Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- no smoking and drugs
- regular physical activity
Exclusion Criteria:
- insufficiency cardiac or respiratory
- carrying a cardiac pacemaker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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.
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. |
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.
Overnight, the subjects stay in their homes.
No intervention during this night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at Day 7 and Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At Day 7 and Day 28
|
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
|
At Day 7 and Day 28
|
Collaborators and Investigators
Investigators
- Study Chair: Guillaume MILLET, PhD, Université Jean Monnet-Saint-Etienne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1108128
- 2011-A00895-36 (Other Identifier: AFSSAPS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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