Protective Effects of Exercise Training (SOMEX)
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Deprivation focused on measuring Exercise training, Endothelial function
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)
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
NCT ID
NCT02820649
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
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
Learn more about this trial
Protective Effects of Exercise Training
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