Protective Effects of Exercise Training

Sleep Deprivation Clinical Trial

— SOMEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820649
• Other study ID #: PDH-1-SMO-2-508
• Secondary ID: 2014_A01103-44
• Status: Completed
• Phase: N/A
• First received: June 23, 2016
• Last updated: June 28, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Sleep deprivation
40 hours of continuous wakefullness

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees	Cetre du sommeil et de la vigilance, APHP

References & Publications (3)

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). doi: 10.1111/jne.12346. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	Inflammation	Plasma levels of inflammatory marquers (TNF-alpha, IL1beta...)	Up to 7:00 during the sleep deprivation day and during the recovery day.	No
Secondary	blood pressure	Mean, systolic and diastolic blood pressure	Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)	Yes
Secondary	PWV	Pulse wave velovity evaluated by echography	Up to 09:00 during the sleep deprivation day	No