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

Primary Purpose

Sleep Deprivation, Healthy Volunteers, Skeletal Muscle

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Normal sleep night
Sleepless night
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

25 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

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;

Sites / Locations

  • Centre Hospitalier de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Normal sleep night

Sleepless night

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
April 20, 2020
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03404427
Brief Title
Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study
Official Title
Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Healthy Volunteers, Skeletal Muscle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
To compare the motor endurance of healthy subjects after a normal sleep night and after a sleepless night.
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal sleep night
Arm Type
Sham Comparator
Arm Description
The first endurance test is the endurance motor control test after a normal sleep night.
Arm Title
Sleepless night
Arm Type
Experimental
Arm Description
The first endurance test is the endurance motor test after a sleepless night.
Intervention Type
Behavioral
Intervention Name(s)
Normal sleep night
Intervention Description
Usual hours of sleep
Intervention Type
Behavioral
Intervention Name(s)
Sleepless night
Intervention Description
Total sleep deprivation the first night
Primary Outcome Measure Information:
Title
Test duration
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 BMI> 18 and <25 kg / m²; Horne and Ostberg score> 31 and <69 ; 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Drouot
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

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

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