Clinical trial NCT02820649: Protective Effects of Exercise Training
Official title: Protective Effects of Exercise Training on Endothelial Dysfunction Induced by Total Sleep Deprivation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: Exercise training
Endothelial function
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
Collaborators: name: Cetre du sommeil et de la vigilance, APHP
First posted: 2016-07-01
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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)

Primary outcomes:
measure: ACh induced Vasodilation during TSD
timeFrame: Up to 09:00 during sleep deprivation (i.e. after 26 hours of wakefulness)
Secondary outcomes:
measure: Insuline Vasodilation
timeFrame: Up to 09:00 during the sleep deprivation day and the recovery day
measure: Heat vasodilation
timeFrame: Up to 9:00 during the sleep deprivation day and during the recovery day
measure: Inflammation
timeFrame: Up to 7:00 during the sleep deprivation day and during the recovery day.
measure: blood pressure
timeFrame: Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)
measure: PWV
timeFrame: Up to 09:00 during the sleep deprivation day
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.