NCT03404427

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 14, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

January 12, 2018

Last Update Submit

April 20, 2020

Conditions

Outcome Measures

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.

    1 hour.

Study Arms (2)

Normal sleep night

SHAM COMPARATOR

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

Behavioral: Normal sleep night

Sleepless night

EXPERIMENTAL

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

Behavioral: Sleepless night

Interventions

Usual hours of sleep

Normal sleep night
Sleepless nightBEHAVIORAL

Total sleep deprivation the first night

Sleepless night

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult male volunteers;
  • 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 BMI\> 18 and \<25 kg / m²;
  • Horne and Ostberg score\> 31 and \<69 ;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Poitiers

Poitiers, Vienne, 86021, France

Location

Related Publications (1)

  • Rault CCS, Heraud Q, Ansquer S, Ragot S, Kostencovska A, Thille AW, Stancu A, Saulnier PJ, Drouot X. Sleep Deprivation in Healthy Males Increases Muscle Afferents, Impairing Motor Preparation and Reducing Endurance. J Clin Neurophysiol. 2024 Nov 27;42(5):457-465. doi: 10.1097/WNP.0000000000001134.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Xavier Drouot

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
When analyzing the results (endurance, magnitude of the premotor potential), the outcomes assessor will not know if it is a normal night or a sleepless night
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: To compare the motor endurance of healthy subjects after a normal sleep night and after a sleepless night.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 19, 2018

Study Start

February 14, 2019

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations