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OpenTrials
Completed

NCT Number: NCT02820649

Protective Effects of Exercise Training

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

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sleep deprivation

Other

40 hours of continuous wakefullness

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut de Recherche Biomedicale des Armees

Other Gov

Collaborators

  • Cetre du sommeil et de la vigilance, APHP

Registry information

Official study title

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

Acronym: SOMEX

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 1, 2016
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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