NCT01606020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

10 months

First QC Date

May 3, 2012

Last Update Submit

August 21, 2012

Conditions

Healthy Volunteers

Keywords

effects of sleep deprivationTranscranial Magnetic Stimulationmale, healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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

    at Day 7 and Day 28

Secondary Outcomes (2)

  • variation of the activation level of excitability and supraspinal / cortical

    At Day 7 and Day 28

  • level variation in test performance from test of Simon

    At Day 7 and Day 28

Study Arms (2)

Sleep deprivation First

ACTIVE COMPARATOR

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 deprivationOther: No intervention

sleep deprivation second

ACTIVE COMPARATOR

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 deprivationOther: No intervention

Interventions

sleep deprivationOTHER

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.

Sleep deprivation Firstsleep deprivation second
No interventionOTHER

Overnight, the subjects stay in their homes. No intervention during this night

Sleep deprivation Firstsleep deprivation second

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no smoking and drugs
  • regular physical activity

You may not qualify if:

  • insufficiency cardiac or respiratory
  • carrying a cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Study Officials

  • Guillaume MILLET, PhD

    Jean Monnet University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 25, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

FR(1)