- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03404427
Effects of Sleep Privation on Sensorimotor Integration of the Upper Limb During a Manual Endurance Test in Healthy Volunteers-Physiological Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vienne
-
Poitiers, Vienne, France, 86021
- Centre Hospitalier de Poitiers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Normal sleep night
The first endurance test is the endurance motor control test after a normal sleep night.
|
Usual hours of sleep
|
Experimental: Sleepless night
The first endurance test is the endurance motor test after a sleepless night.
|
Total sleep deprivation the first night
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test duration
Time Frame: 1 hour.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xavier Drouot, Poitiers university hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HANDY-SLEEP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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