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Protective Effects of Exercise Training (SOMEX)

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ClinicalTrials.gov Identifier: NCT02820649
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
Cetre du sommeil et de la vigilance, APHP
Information provided by (Responsible Party):
Institut de Recherche Biomedicale des Armees

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


Condition or disease Intervention/treatment Phase
Sleep Deprivation Other: Sleep deprivation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Protective Effects of Exercise Training on Endothelial Dysfunction Induced by Total Sleep Deprivation in Healthy Subjects
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise training
7 weeks of exercise training
Other: Sleep deprivation
40 hours of continuous wakefullness

Sham Comparator: Control
Sedentary group
Other: Sleep deprivation
40 hours of continuous wakefullness




Primary Outcome Measures :
  1. ACh induced Vasodilation during TSD [ Time Frame: Up to 09:00 during sleep deprivation (i.e. after 26 hours of wakefulness) ]
    Cutaneous vasodilation (in % Baseline) induced by local application of Acethylcholine


Secondary Outcome Measures :
  1. Insuline Vasodilation [ Time Frame: Up to 09:00 during the sleep deprivation day and the recovery day ]
    Cutaneous vasodilation (in % Baseline) induced by local application of insulin

  2. Heat vasodilation [ Time Frame: Up to 9:00 during the sleep deprivation day and during the recovery day ]
    Cutaneous vasodilation (in % Baseline) induced by local application of heat (42°C)

  3. Inflammation [ Time Frame: Up to 7:00 during the sleep deprivation day and during the recovery day. ]
    Plasma levels of inflammatory marquers (TNF-alpha, IL1beta...)

  4. blood pressure [ Time Frame: Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation) ]
    Mean, systolic and diastolic blood pressure

  5. PWV [ Time Frame: Up to 09:00 during the sleep deprivation day ]
    Pulse wave velovity evaluated by echography



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut de Recherche Biomedicale des Armees
ClinicalTrials.gov Identifier: NCT02820649    
Other Study ID Numbers: PDH-1-SMO-2-508
2014_A01103-44 ( Other Identifier: IDRCB ANSM )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut de Recherche Biomedicale des Armees:
Exercise training
Endothelial function
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders