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Protective Effects of Exercise Training (SOMEX)

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Deprivation focused on measuring Exercise training, Endothelial function

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Men
  • 18 - 35 yrs

Exclusion Criteria:

  • Consumming 400 mg of caffeine per day,
  • Body mass index (BMI) greater than 30 kg/m²,
  • Taking medication.
  • Excessive daytime somnolence (Epworth Sleepiness Scale >9)
  • Sleep complaints (Pittsburgh Sleep Quality Index >5)
  • Inability to be considered as an intermediate chronotype on the Horne and Ostberg questionnaire (score <31 or >69)
  • Traines subject (Ricci Gagnon questionnaire >35)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Exercise training

    Control

    Arm Description

    7 weeks of exercise training

    Sedentary group

    Outcomes

    Primary Outcome Measures

    ACh induced Vasodilation during TSD
    Cutaneous vasodilation (in % Baseline) induced by local application of Acethylcholine

    Secondary Outcome Measures

    Insuline Vasodilation
    Cutaneous vasodilation (in % Baseline) induced by local application of insulin
    Heat vasodilation
    Cutaneous vasodilation (in % Baseline) induced by local application of heat (42°C)
    Inflammation
    Plasma levels of inflammatory marquers (TNF-alpha, IL1beta...)
    blood pressure
    Mean, systolic and diastolic blood pressure
    PWV
    Pulse wave velovity evaluated by echography

    Full Information

    First Posted
    June 23, 2016
    Last Updated
    June 28, 2016
    Sponsor
    Institut de Recherche Biomedicale des Armees
    Collaborators
    Cetre du sommeil et de la vigilance, APHP
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02820649
    Brief Title
    Protective Effects of Exercise Training
    Acronym
    SOMEX
    Official Title
    Protective Effects of Exercise Training on Endothelial Dysfunction Induced by Total Sleep Deprivation in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut de Recherche Biomedicale des Armees
    Collaborators
    Cetre du sommeil et de la vigilance, APHP

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Rationale. Sleep loss is a risk factor for cardiovascular events mediated through endothelial dysfunction. Objective. To determine if 7 weeks of exercise training can limit cardiovascular dysfunction induced by total sleep deprivation (TSD) in healthy young men. Methods: 16 subjects will be examined during 40-h TSD, both before and after 7 weeks of interval exercise training. Vasodilatation induced by ACh, insulin and heat (42°C) as well as pulse wave velocity (PWV), blood pressure and heart rate (HR) will be assessed at baseline, during TSD, and after one night of sleep recovery. Biomarkers of endothelial activation, inflammation, and hormones will bemeasured from morning blood samples at 07:00

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Deprivation
    Keywords
    Exercise training, Endothelial function

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise training
    Arm Type
    Experimental
    Arm Description
    7 weeks of exercise training
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Sedentary group
    Intervention Type
    Other
    Intervention Name(s)
    Sleep deprivation
    Intervention Description
    40 hours of continuous wakefullness
    Primary Outcome Measure Information:
    Title
    ACh induced Vasodilation during TSD
    Description
    Cutaneous vasodilation (in % Baseline) induced by local application of Acethylcholine
    Time Frame
    Up to 09:00 during sleep deprivation (i.e. after 26 hours of wakefulness)
    Secondary Outcome Measure Information:
    Title
    Insuline Vasodilation
    Description
    Cutaneous vasodilation (in % Baseline) induced by local application of insulin
    Time Frame
    Up to 09:00 during the sleep deprivation day and the recovery day
    Title
    Heat vasodilation
    Description
    Cutaneous vasodilation (in % Baseline) induced by local application of heat (42°C)
    Time Frame
    Up to 9:00 during the sleep deprivation day and during the recovery day
    Title
    Inflammation
    Description
    Plasma levels of inflammatory marquers (TNF-alpha, IL1beta...)
    Time Frame
    Up to 7:00 during the sleep deprivation day and during the recovery day.
    Title
    blood pressure
    Description
    Mean, systolic and diastolic blood pressure
    Time Frame
    Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)
    Title
    PWV
    Description
    Pulse wave velovity evaluated by echography
    Time Frame
    Up to 09:00 during the sleep deprivation day

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Men 18 - 35 yrs Exclusion Criteria: Consumming 400 mg of caffeine per day, Body mass index (BMI) greater than 30 kg/m², Taking medication. Excessive daytime somnolence (Epworth Sleepiness Scale >9) Sleep complaints (Pittsburgh Sleep Quality Index >5) Inability to be considered as an intermediate chronotype on the Horne and Ostberg questionnaire (score <31 or >69) Traines subject (Ricci Gagnon questionnaire >35)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25932797
    Citation
    Sauvet F, Drogou C, Bougard C, Arnal PJ, Dispersyn G, Bourrilhon C, Rabat A, Van Beers P, Gomez-Merino D, Faraut B, Leger D, Chennaoui M. Vascular response to 1 week of sleep restriction in healthy subjects. A metabolic response? Int J Cardiol. 2015;190:246-55. doi: 10.1016/j.ijcard.2015.04.119. Epub 2015 Apr 16.
    Results Reference
    background
    PubMed Identifier
    26647769
    Citation
    Arnal PJ, Drogou C, Sauvet F, Regnauld J, Dispersyn G, Faraut B, Millet GY, Leger D, Gomez-Merino D, Chennaoui M. Effect of Sleep Extension on the Subsequent Testosterone, Cortisol and Prolactin Responses to Total Sleep Deprivation and Recovery. J Neuroendocrinol. 2016 Feb;28(2):12346. doi: 10.1111/jne.12346.
    Results Reference
    background
    PubMed Identifier
    26194565
    Citation
    Arnal PJ, Sauvet F, Leger D, van Beers P, Bayon V, Bougard C, Rabat A, Millet GY, Chennaoui M. Benefits of Sleep Extension on Sustained Attention and Sleep Pressure Before and During Total Sleep Deprivation and Recovery. Sleep. 2015 Dec 1;38(12):1935-43. doi: 10.5665/sleep.5244.
    Results Reference
    background
    PubMed Identifier
    28089456
    Citation
    Sauvet F, Arnal PJ, Tardo-Dino PE, Drogou C, Van Beers P, Bougard C, Rabat A, Dispersyn G, Malgoyre A, Leger D, Gomez-Merino D, Chennaoui M. Protective effects of exercise training on endothelial dysfunction induced by total sleep deprivation in healthy subjects. Int J Cardiol. 2017 Apr 1;232:76-85. doi: 10.1016/j.ijcard.2017.01.049. Epub 2017 Jan 5.
    Results Reference
    derived

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    Protective Effects of Exercise Training

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