NCT02820649

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

June 23, 2016

Last Update Submit

June 28, 2016

Conditions

Sleep Deprivation

Keywords

Exercise trainingEndothelial function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Insuline Vasodilation

    Up to 09:00 during the sleep deprivation day and the recovery day

  • Heat vasodilation

    Up to 9:00 during the sleep deprivation day and during the recovery day

  • Inflammation

    Up to 7:00 during the sleep deprivation day and during the recovery day.

  • blood pressure

    Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)

  • PWV

    Up to 09:00 during the sleep deprivation day

Study Arms (2)

Exercise training

EXPERIMENTAL

7 weeks of exercise training

Other: Sleep deprivation

Control

SHAM COMPARATOR

Sedentary group

Other: Sleep deprivation

Interventions

Sleep deprivationOTHER

40 hours of continuous wakefullness

ControlExercise training

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Men
  • yrs

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25932797BACKGROUND

  • 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.

    PMID: 26647769BACKGROUND

  • 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.

    PMID: 26194565BACKGROUND

  • 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.

    PMID: 28089456DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 1, 2016

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

March 1, 2016

Last Updated

July 1, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share