Healthy VolunteersPrivSomNCT01606020
Sleep Deprivation : Effects on Driving Performance and Central Fatigue
A study testing sleep deprivation in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal versus prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- sleep deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Jul 2012
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no smoking and drugs
- regular physical activity
Who cannot join
- insufficiency cardiac or respiratory
- carrying a cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sleep Deprivation on Driving Performance and Central Fatigue
The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal versus prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD.
Read the detailed description
The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal vs. prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD. However, the causes of this accentuated fatigability in endurance exercise with sleep deficit are not known. Several hypotheses have been proposed such as lower pH before exercise, lower ventilation due to depreciated response to hypercapnia/hypoxia, or haemodilution. Yet the most plausible explanation is a lower tolerance to prolonged exercise because SD increases the rate of perceived exertion. Another potential effect of SD is an alteration of central command during exercise. The literature is rather scarce on this topic and is only based on a few animal studies. In humans, no effect of SD on maximal strength has been reported so that maximal voluntary activation should in theory not be altered. Transcranial Magnetic Stimulation (TMS), that allows to induce a motor response from its cortical origin (and to measure the resulting contraction), is a promising tool to explore neuromuscular function. TMS has been used only in three studies after SD, none of them involving exercise and none of them measuring mechanical responses (i.e. only EMG responses, such as motor evoked potential, were measured). In addition, the results of these three studies are contradictory. The effects of SD on central fatigue (i.e. increase of the activation deficit during exercise) have never been investigated. The goal of this experiment is thus to test the hypothesis that an increase in central fatigue (at supraspinal level) in SD can participate to performance alteration during a prolonged exercise. For that purpose, measurements of neuromuscular function particularly dedicated to assess central fatigue will be performed before and after SD but also when combining SD and a fatiguing exercise conducted until exhaustion.
- Conditions
- Healthy Volunteers
- Being tested
- sleep deprivation, No intervention
- Keywords
- effects of sleep deprivation, Transcranial Magnetic Stimulation, male, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep deprivationOther
Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep.
No interventionOther
Overnight, the subjects stay in their homes. No intervention during this night
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation First | Active comparator | First night D7 :
Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep.
Second night D28 :
Overnight, the subjects stay in their homes. No intervention during this night. Receives: Other: sleep deprivation; Other: No intervention |
| sleep deprivation second | Active comparator | First night D7 :
Overnight, the subjects stay in their homes. No intervention during this night.
Second night D28 :
Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep. Receives: Other: sleep deprivation; Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal between before and after endurance exercise after a night of sleep deprivation
Measured: at Day 7 and Day 28
Secondary outcomes (2)
variation of the activation level of excitability and supraspinal / cortical
variation of the activation level of excitability and supraspinal / cortical inhibition after a night of sleep deprivation
Measured: At Day 7 and Day 28
level variation in test performance from test of Simon
level variation in test performance from test of Simon before, during and after endurance exercise following a night of sleep deprivation
Measured: At Day 7 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume MILLET, PhD, Study chair, Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606020
- Sponsor's protocol ID
- 1108128
- Other IDs
- 2011-A00895-36
- Acronym
- PrivSom
- Status last verified
- Aug 2012
- First submitted
- 3 May 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Deprivation on Driving Performance and Central Fatigue
- ClinicalTrials.gov ID
- NCT01606020
- Acronym / sponsor ID
- PrivSom / 1108128
- Conditions
- Healthy Volunteers
- Keywords
- effects of sleep deprivation, Transcranial Magnetic Stimulation, male, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 May 2012 (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.
The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal versus prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD.
Detailed description
The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal vs. prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD. However, the causes of this accentuated fatigability in endurance exercise with sleep deficit are not known. Several hypotheses have been proposed such as lower pH before exercise, lower ventilation due to depreciated response to hypercapnia/hypoxia, or haemodilution. Yet the most plausible explanation is a lower tolerance to prolonged exercise because SD increases the rate of perceived exertion. Another potential effect of SD is an alteration of central command during exercise. The literature is rather scarce on this topic and is only based on a few animal studies. In humans, no effect of SD on maximal strength has been reported so that maximal voluntary activation should in theory not be altered. Transcranial Magnetic Stimulation (TMS), that allows to induce a motor response from its cortical origin (and to measure the resulting contraction), is a promising tool to explore neuromuscular function. TMS has been used only in three studies after SD, none of them involving exercise and none of them measuring mechanical responses (i.e. only EMG responses, such as motor evoked potential, were measured). In addition, the results of these three studies are contradictory. The effects of SD on central fatigue (i.e. increase of the activation deficit during exercise) have never been investigated. The goal of this experiment is thus to test the hypothesis that an increase in central fatigue (at supraspinal level) in SD can participate to performance alteration during a prolonged exercise. For that purpose, measurements of neuromuscular function particularly dedicated to assess central fatigue will be performed before and after SD but also when combining SD and a fatiguing exercise conducted until exhaustion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation First | Active comparator | Other: sleep deprivation, Other: No interventionFirst night D7 : Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep. Second night D28 : Overnight, the subjects stay in their homes. No intervention during this night. |
| sleep deprivation second | Active comparator | Other: sleep deprivation, Other: No interventionFirst night D7 : Overnight, the subjects stay in their homes. No intervention during this night. Second night D28 : Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- no smoking and drugs
- regular physical activity
Key exclusion criteria (2 listed)
- insufficiency cardiac or respiratory
- carrying a cardiac pacemaker
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 deprivationOvernight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep. | Other | Sleep deprivation First, sleep deprivation second |
| No interventionOvernight, the subjects stay in their homes. No intervention during this night | Other | Sleep deprivation First, sleep deprivation second |
Primary outcome
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal
Time frame: at Day 7 and Day 28
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal between before and after endurance exercise after a night of sleep deprivation
2 secondary outcomes
variation of the activation level of excitability and supraspinal / cortical
Time frame: At Day 7 and Day 28
level variation in test performance from test of Simon
Time frame: At Day 7 and Day 28
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 22 Aug 2012.
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Screening Protocol
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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.
Guillaume MILLET, PhD study chair
Jean Monnet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep deprivation in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 2 inclusion and 2 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
change value of the level of maximal voluntary activation of quadriceps muscle supraspinal (time frame: at Day 7 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2012.