ClinicalTrials.gg
CompletedNCT03404427Updated Apr 21, 2020

Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study

An interventional study of Normal sleep night and Sleepless night in Sleep Deprivation, Healthy Volunteers and Skeletal Muscle, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to male participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Sleep Deprivation with a site in France — 7 open to participants now, 8 under way, none of them phase 3. Sleep Deprivation · France.

Enrollment
20th of 23
21 · median 40
Started
2019
with 1 other
No phase
21 of 31
5 open now
Registered
9th of 31
by date
Lead sponsor
2 of 31
Poitiers University Hospital

Among the 31 studies in Sleep Deprivation with a site in France, this one is the 20th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2019, is one of 21 with no phase, and was the 9th registered.

Sleep Deprivation

314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.

Browse Sleep Deprivation studies →

Open to participants now

7 of the 31 studies in Sleep Deprivation with a site in France are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.

This study: 25 Years to 45 Years · male · healthy volunteers too.

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02

Study summary

The investigator showed that a night of sleep deprivation halved the duration of an inspiratory endurance test and that this loss of endurance could be secondary to a lack of activation of the pre-motor cortex. However, the inspiratory endurance test is associated with a feeling of dyspnea that could lead to premature arrest, and the inspiratory drive is complex, both automatic and voluntary. The investigator can reproduce this results on a simpler drive.

During the execution of an exercise involving repeated contractions of the hand it is possible to record the activation of the pre-motor cortex corresponding to the phase of preparation of the movement. The amplitude of these premotor potentials is proportional to the developed motive force.

The purpose of this study is to assess the impact of sleep deprivation on the muscular endurance of non-dominant in healthy subjects.

Hypothesis: Sleep deprivation causes a decrease in manual motor endurance by decreasing cortical pre-motor control.

Main objective: To compare the motor endurance of healthy subjects after a night's sleep and after a sleepless night.

Secondary objective: To compare the amplitude of premature cortical control at the beginning of the endurance test after a night's sleep and after a sleepless night.

03

Conditions studied

  • Sleep Deprivation
  • Healthy Volunteers
  • Skeletal Muscle

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04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult male volunteers;
  • 25 to 45 years old
  • regularly sleeping more than 6 hours per night;
  • no excessive consumers of coffee (\<3 espressos / day);
  • absence of muscular or neurological pathology ;
  • with a > 18 and \<25 kg / m²;
  • Horne and Ostberg score> 31 and \<69 ;

Exclusion criteria

Exclusion Criteria:

  • female sex
  • history of neuromuscular disease ;
  • implanted metallic or electronic equipment (vascular stent, ocular implant, pacemaker ...)
  • history of epilepsy, or discomfort after sleep deprivation ;
  • poor sleepers (PSQI> 5);
  • exercising an activity in staggered hours;
  • regularly performing more than 2 nights without sleep per month;
  • taking drugs interfering with sleep (antidepressants, benzodiazepines ...);
  • having crossed 4 time zones in the previous 4 weeks.
  • current participation in another clinical research study;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Sham comparator
    Normal sleep night

    The first endurance test is the endurance motor control test after a normal sleep night.

    Behavioral: Normal sleep night

  • Experimental
    Sleepless night

    The first endurance test is the endurance motor test after a sleepless night.

    Behavioral: Sleepless night

Interventions

  • BehavioralNormal sleep night

    Usual hours of sleep

  • BehavioralSleepless night

    Total sleep deprivation the first night

06

What researchers measure

Primary outcomes

  1. Test duration

    Time, in minutes, measured between the beginning of the endurance test and the end of the test, defined by the volunteer's inability to maintain a force of at least 30% of the maximum strength for 5 seconds.

    Time frame: 1 hour.

07

Study locations

1 site
  • Centre Hospitalier de Poitiers
    Poitiers, Vienne 86021, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2019 to primary completion in Mar 2020, 12 months.

Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 12 months is below that.

Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2018
First posted
Jan 19, 2018
StartActual
Feb 14, 2019
Primary completionActual
Mar 4, 2020
CompletionActual
Mar 4, 2020
Last update
Apr 21, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03404427
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Feb 14, 2019
Primary completion
Mar 4, 2020
Completion
Mar 4, 2020
Last update
Apr 21, 2020

Study contacts

Xavier Drouot
principal investigator · Poitiers University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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