Sleep DeprivationSOMEXNCT02820649
Protective Effects of Exercise Training
A study testing Sleep deprivation in people with Sleep Deprivation, run by Institut de Recherche Biomedicale des Armees.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep deprivation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Men
- 18 - 35 yrs
Who cannot join
- 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)
About this study
Official title: 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
- Conditions
- Sleep Deprivation
- Being tested
- Sleep deprivation
- Keywords
- Exercise training, Endothelial function
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationOther
40 hours of continuous wakefullness
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 7 weeks of exercise training Receives: Other: Sleep deprivation |
| Control | Sham comparator | Sedentary group Receives: Other: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACh induced Vasodilation during TSD
Cutaneous vasodilation (in % Baseline) induced by local application of Acethylcholine
Measured: Up to 09:00 during sleep deprivation (i.e. after 26 hours of wakefulness)
Secondary outcomes (5)
Insuline Vasodilation
Cutaneous vasodilation (in % Baseline) induced by local application of insulin
Measured: 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)
Measured: Up to 9:00 during the sleep deprivation day and during the recovery day
Inflammation
Plasma levels of inflammatory marquers (TNF-alpha, IL1beta...)
Measured: Up to 7:00 during the sleep deprivation day and during the recovery day.
blood pressure
Mean, systolic and diastolic blood pressure
Measured: Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)
PWV
Pulse wave velovity evaluated by echography
Measured: Up to 09:00 during the sleep deprivation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Collaborators
- Cetre du sommeil et de la vigilance, APHP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820649
- Sponsor's protocol ID
- PDH-1-SMO-2-508
- Other IDs
- 2014_A01103-44
- Acronym
- SOMEX
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25932797Arnal 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.
PubMed 26647769Arnal 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.
PubMed 26194565Sauvet 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.
PubMed 28089456
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Exercise Training on Endothelial Dysfunction Induced by Total Sleep Deprivation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02820649
- Acronym / sponsor ID
- SOMEX / PDH-1-SMO-2-508
- Conditions
- Sleep Deprivation
- Keywords
- Exercise training, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Collaborators
- Cetre du sommeil et de la vigilance, APHP
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Sleep deprivation7 weeks of exercise training |
| Control | Sham comparator | Other: Sleep deprivationSedentary group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Men
- 18 - 35 yrs
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep deprivation40 hours of continuous wakefullness | Other | Control, Exercise training |
Primary outcome
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
5 secondary outcomes
Insuline Vasodilation
Time frame: Up to 09:00 during the sleep deprivation day and the recovery day
Heat vasodilation
Time frame: Up to 9:00 during the sleep deprivation day and during the recovery day
Inflammation
Time frame: Up to 7:00 during the sleep deprivation day and during the recovery day.
blood pressure
Time frame: Every 3 hours during the 40 hours of wakefullness (i.e. total sleep deprivation)
PWV
Time frame: Up to 09:00 during the sleep deprivation day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Background: PubMed 25932797Sauvet 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.
- Background: PubMed 26647769Arnal 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.
- Background: PubMed 26194565Arnal 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.
- Derived from this study: PubMed 28089456Sauvet 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.
- Individual participant dataSharing planned: No
Related trials for Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Recruiting
Effect of Sleep Extension in Prevention to Sleep Deprivation
Healthy
Not yet recruiting
Evolution of Sleep in Intensive Care Unit Patients
ICU, Sleep Deprivation
Active, not recruiting
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Sleep Deprivation, Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation in people with Sleep Deprivation, run by Institut de Recherche Biomedicale des Armees.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACh induced Vasodilation during TSD (time frame: Up to 09:00 during sleep deprivation (i.e. after 26 hours of wakefulness)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820649, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.