Protective Effects of Exercise Training (SOMEX)

Protective Effects of Exercise Training on Endothelial Dysfunction Induced by Total Sleep Deprivation in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation
• Intervention / Treatment: Other: Sleep deprivation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insuline Vasodilation	Cutaneous vasodilation (in % Baseline) induced by local application of insulin	Up to 09:00 during the sleep deprivation day and the recovery day
Heat vasodilation	Cutaneous vasodilation (in % Baseline) induced by local application of heat (42°C)	Up to 9:00 during the sleep deprivation day and during the recovery day
Inflammation	Plasma levels of inflammatory marquers (TNF-alpha, IL1beta...)	Up to 7:00 during the sleep deprivation day and during the recovery day.
blood pressure	Mean, systolic and diastolic blood pressure	Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)
PWV	Pulse wave velovity evaluated by echography	Up to 09:00 during the sleep deprivation day

Collaborators and Investigators

• Sponsor: Institut de Recherche Biomedicale des Armees
• Collaborators: Cetre du sommeil et de la vigilance, APHP

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Estimate): July 1, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Endothelial function; Exercise training
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: PDH-1-SMO-2-508; 2014_A01103-44 (Other Identifier: IDRCB ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No