Sleep DeprivationBankingSleepNCT02352272
Benefits of Sleep Extension on Performances During Total Sleep Deprivation (BankingSleep)
A study testing Total Sleep deprivation in people with Sleep Deprivation, run by Institut de Recherche Biomedicale des Armees at 1 site in France.
Trial summary
Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive performances before, during total sleep deprivation (39 hours continuous awaking) and after a subsequent recovery sleep. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Total Sleep deprivation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Dec 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subject
- voluntary
Who cannot join
- an average of > 9 h and < 6 h sleep per night
- a difference > 45 min between week night and weekend night
- sleep debt
- sleep disorders
- medication
- alcool or toxic consumption
- up to 300 mg caffeine per day consumption
- neurologic, cardiovascular, metabolic, pulmonary psychiatric disease or disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Sleep Extension on Cognitive and Physical Performances During Baseline, Total Sleep Deprivation and Recovery (BankingSleep)
Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive performances before, during total sleep deprivation (39 hours continuous awaking) and after a subsequent recovery sleep.
Design: Subjects participated in two experimental conditions (randomized cross-over design): extended sleep (10-h in bed, EXT) and habitual sleep (8-h in bed, HAB). In each condition, subjects performed two consecutive phases: (1) six nights of either EXT or HAB (2) three experiments days in-laboratory:baseline (BASE), sleep deprivation (TSD) and after 10 h of recovery sleep(REC). Performance tests were administered every 3 hours over the 3-d in laboratory.
Read more
Setting: This cross-over and randomized study was conducted under standardized laboratory conditions with continuous polysomnographic recording Participants: 14 healthy men (age range: 26-37 years) participated in the study.
Interventions: EXT vs. HAB sleep durations prior to total sleep deprivation (39 hr continuous awaking).
Read the detailed description
Many human endeavors require high-level cognitive performance situations (e.g., health care, military operations, space flight) along the whole nycthemera (i.e. the 24-h cycle).
It has long been established that both acute total sleep deprivation (TSD) and chronic sleep restriction impair ability to maintain wakefulness, increase subjective sleepiness and sleep propensity, and most critically reduce various aspects of cognitive performance. In studies conducted in both laboratory setting and different professional situations inducing insufficient sleep, the most consistently and dramatically impacted cognitive capacities were sustained attention and alertness. This degradation of cognitive performance after a period of sleep deprivation is linked to an increase of sleep pressure, e.g. a reduction in the latency to sleep onset or increase of number of involuntary micro sleeps.
To identify countermeasures to deleterious effects of sleep deprivation is critical in many professional areas.
Management of wake/sleep cycle appears to have an important impact of alertness during sleep deprivation (e.g. sleep habits or physical activity, see the review. Recently, Rupp and coll. (2012) reported that one week of sleep extension realized before one week of sleep restriction (3 h/night) influence the rate of degradation of cognitive performance and alertness during this period and the subsequent recovery period. In other words, they proposed that sleep can be "banked" before a period of sleep loss and may help sustain performance and alertness. With a different experimental paradigm (i.e. without subsequent sleep deprivation), studies have shown that sleep extension (realized over different periods of time) may improve physical performance, attentional performance, or mood. The fact of increasing total sleep time over a period of time represents an attractive non-pharmacological countermeasure to limit the deleterious effects on performance induced by sleep privation. However, there is no study with cross-over and randomized design to assess effect on relatively short period (6 nights) of sleep extension on performance before, during total sleep deprivation and recovery. Moreover, there is no direct measurement of sleep pressure as continuous EEG monitoring to quantify micro sleep episode during period of sleep deprivation and effect of sleep extension on physical performance is not known.
Hence, the aim of this study was to assess the effects of 6 nights of sleep extension (EXT) on physical and cognitive performances, alertness and homeostatic sleep pressure before, during total sleep deprivation and the subsequent recovery day.
The investigators hypothesized that EXT would: i) partly prevents the physical and cognitive performances degradation-induced by total sleep deprivation ii) decreases the sleep pressure before, during and after total sleep deprivation and iii) improves the recovery speed of physical and cognitive performances.
- Conditions
- Sleep Deprivation
- Being tested
- Total Sleep deprivation
- Keywords
- sleep extension, attention, physical performance
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Sleep deprivationOther
Also called TSD
Subject are submitted to 39 hours of continuous awaking in laboratory and a recovery night
| Study group | Role | What they receive |
|---|---|---|
| Sleep extension | Experimental | Subject spend 10 hours Time in bed per day during 6 nights. This period is follow by a total sleep deprivation intervention (i.e. 39 hours awaking) in laboratory. Receives: Other: Total Sleep deprivation |
| Habitual sleep | Sham comparator | Subject respect their habitual Time in bed during 6 nights. This period is follow by a total sleep deprivation intervention (i.e. 39 hours awaking) in laboratory. Receives: Other: Total Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of errors during PVT (n)
number of errors (<100ms or > 500ms) during a10 min Psychomotor Vigilance test (PVT)
Measured: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Secondary outcomes (6)
median speed during PVT (s-1)
median speed response during a10 min Psychomotor Vigilance test (PVT)
Measured: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
number of micro sleep (n)
number of micro sleep (> 5 sec) per hour during baseline, TSD and recovery
Measured: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Sleep latency (min)
Sleep latency during multiple sleep latency test (MSLT)
Measured: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Muscular force (dyn)
Muscular force developed by the subject
Measured: At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)
Response to Trans Magnetic Stimulation (%)
Effect of trans magnetic stimulation on Muscular force developed by the subject
Measured: At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)
Polysomnographic classification (N1, N2, N3, REM)
Evaluation of the duration of each sleep stages during the night before and after TSD
Measured: night during DA (Baseline) and D3 (Recovery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fabien SAUVET, Institut de Recherche Biomedicale des Armees
- Investigators
- Damien LEGER, MD, PhD, Study chair, Sleep center, Hotel Dieu ParisMounir CHENNAOUI, PhD, Study director, Institut de Recherche Biomedicale des ArmeesFabien SAUVET, MD, PhD, Principal investigator, Institut de Recherche Biomedicale des Armees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352272
- Sponsor's protocol ID
- 14ca703op1
- Other IDs
- 2013-A01403-42
- Acronym
- BankingSleep
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rupp TL, Wesensten NJ, Bliese PD, Balkin TJ. Banking sleep: realization of benefits during subsequent sleep restriction and recovery. Sleep. 2009 Mar;32(3):311-21. doi: 10.1093/sleep/32.3.311.
PubMed 19294951Chennaoui M, Sauvet F, Drogou C, Van Beers P, Langrume C, Guillard M, Gourby B, Bourrilhon C, Florence G, Gomez-Merino D. Effect of one night of sleep loss on changes in tumor necrosis factor alpha (TNF-alpha) levels in healthy men. Cytokine. 2011 Nov;56(2):318-24. doi: 10.1016/j.cyto.2011.06.002. Epub 2011 Jul 6.
PubMed 21737301Sauvet F, Leftheriotis G, Gomez-Merino D, Langrume C, Drogou C, Van Beers P, Bourrilhon C, Florence G, Chennaoui M. Effect of acute sleep deprivation on vascular function in healthy subjects. J Appl Physiol (1985). 2010 Jan;108(1):68-75. doi: 10.1152/japplphysiol.00851.2009. Epub 2009 Nov 12.
PubMed 19910332Chennaoui M, Arnal PJ, Sauvet F, Leger D. Sleep and exercise: a reciprocal issue? Sleep Med Rev. 2015 Apr;20:59-72. doi: 10.1016/j.smrv.2014.06.008. Epub 2014 Jun 30.
PubMed 25127157Temesi J, Arnal PJ, Davranche K, Bonnefoy R, Levy P, Verges S, Millet GY. Does central fatigue explain reduced cycling after complete sleep deprivation? Med Sci Sports Exerc. 2013 Dec;45(12):2243-53. doi: 10.1249/MSS.0b013e31829ce379.
PubMed 23760468Rabat A, Arnal PJ, Monnard H, Erblang M, Van Beers P, Bougard C, Drogou C, Guillard M, Sauvet F, Leger D, Gomez-Merino D, Chennaoui M. Limited Benefit of Sleep Extension on Cognitive Deficits During Total Sleep Deprivation: Illustration With Two Executive Processes. Front Neurosci. 2019 Jun 19;13:591. doi: 10.3389/fnins.2019.00591. eCollection 2019.
PubMed 31275098
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Sleep Extension on Cognitive and Physical Performances During Baseline, Total Sleep Deprivation and Recovery (BankingSleep)
- ClinicalTrials.gov ID
- NCT02352272
- Acronym / sponsor ID
- BankingSleep / 14ca703op1
- Conditions
- Sleep Deprivation
- Keywords
- sleep extension, attention, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Feb 2015 (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.
Objectives: investigate the effects of 6 nights of sleep extension on physical and cognitive performances before, during total sleep deprivation (39 hours continuous awaking) and after a subsequent recovery sleep.
Design: Subjects participated in two experimental conditions (randomized cross-over design): extended sleep (10-h in bed, EXT) and habitual sleep (8-h in bed, HAB). In each condition, subjects performed two consecutive phases: (1) six nights of either EXT or HAB (2) three experiments days in-laboratory:baseline (BASE), sleep deprivation (TSD) and after 10 h of recovery sleep(REC). Performance tests were administered every 3 hours over the 3-d in laboratory.
Setting: This cross-over and randomized study was conducted under standardized laboratory conditions with continuous polysomnographic recording Participants: 14 healthy men (age range: 26-37 years) participated in the study.
Interventions: EXT vs. HAB sleep durations prior to total sleep deprivation (39 hr continuous awaking).
Detailed description
Many human endeavors require high-level cognitive performance situations (e.g., health care, military operations, space flight) along the whole nycthemera (i.e. the 24-h cycle).
It has long been established that both acute total sleep deprivation (TSD) and chronic sleep restriction impair ability to maintain wakefulness, increase subjective sleepiness and sleep propensity, and most critically reduce various aspects of cognitive performance. In studies conducted in both laboratory setting and different professional situations inducing insufficient sleep, the most consistently and dramatically impacted cognitive capacities were sustained attention and alertness. This degradation of cognitive performance after a period of sleep deprivation is linked to an increase of sleep pressure, e.g. a reduction in the latency to sleep onset or increase of number of involuntary micro sleeps.
To identify countermeasures to deleterious effects of sleep deprivation is critical in many professional areas.
Management of wake/sleep cycle appears to have an important impact of alertness during sleep deprivation (e.g. sleep habits or physical activity, see the review. Recently, Rupp and coll. (2012) reported that one week of sleep extension realized before one week of sleep restriction (3 h/night) influence the rate of degradation of cognitive performance and alertness during this period and the subsequent recovery period. In other words, they proposed that sleep can be "banked" before a period of sleep loss and may help sustain performance and alertness. With a different experimental paradigm (i.e. without subsequent sleep deprivation), studies have shown that sleep extension (realized over different periods of time) may improve physical performance, attentional performance, or mood. The fact of increasing total sleep time over a period of time represents an attractive non-pharmacological countermeasure to limit the deleterious effects on performance induced by sleep privation. However, there is no study with cross-over and randomized design to assess effect on relatively short period (6 nights) of sleep extension on performance before, during total sleep deprivation and recovery. Moreover, there is no direct measurement of sleep pressure as continuous EEG monitoring to quantify micro sleep episode during period of sleep deprivation and effect of sleep extension on physical performance is not known.
Hence, the aim of this study was to assess the effects of 6 nights of sleep extension (EXT) on physical and cognitive performances, alertness and homeostatic sleep pressure before, during total sleep deprivation and the subsequent recovery day.
The investigators hypothesized that EXT would: i) partly prevents the physical and cognitive performances degradation-induced by total sleep deprivation ii) decreases the sleep pressure before, during and after total sleep deprivation and iii) improves the recovery speed of physical and cognitive performances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep extension | Experimental | Other: Total Sleep deprivationSubject spend 10 hours Time in bed per day during 6 nights. This period is follow by a total sleep deprivation intervention (i.e. 39 hours awaking) in laboratory. |
| Habitual sleep | Sham comparator | Other: Total Sleep deprivationSubject respect their habitual Time in bed during 6 nights. This period is follow by a total sleep deprivation intervention (i.e. 39 hours awaking) in laboratory. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subject
- voluntary
Key exclusion criteria (8 listed)
- an average of > 9 h and < 6 h sleep per night
- a difference > 45 min between week night and weekend night
- sleep debt
- sleep disorders
- medication
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 |
|---|---|---|
| Total Sleep deprivationAlso: TSDSubject are submitted to 39 hours of continuous awaking in laboratory and a recovery night | Other | Habitual sleep, Sleep extension |
Primary outcome
Number of errors during PVT (n)
Time frame: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
number of errors (<100ms or > 500ms) during a10 min Psychomotor Vigilance test (PVT)
6 secondary outcomes
median speed during PVT (s-1)
Time frame: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
number of micro sleep (n)
Time frame: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Sleep latency (min)
Time frame: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Muscular force (dyn)
Time frame: At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)
Response to Trans Magnetic Stimulation (%)
Time frame: At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)
Polysomnographic classification (N1, N2, N3, REM)
Time frame: night during DA (Baseline) and D3 (Recovery)
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 2 Feb 2015.
- Background: PubMed 19294951Rupp TL, Wesensten NJ, Bliese PD, Balkin TJ. Banking sleep: realization of benefits during subsequent sleep restriction and recovery. Sleep. 2009 Mar;32(3):311-21. doi: 10.1093/sleep/32.3.311.
- Background: PubMed 21737301Chennaoui M, Sauvet F, Drogou C, Van Beers P, Langrume C, Guillard M, Gourby B, Bourrilhon C, Florence G, Gomez-Merino D. Effect of one night of sleep loss on changes in tumor necrosis factor alpha (TNF-alpha) levels in healthy men. Cytokine. 2011 Nov;56(2):318-24. doi: 10.1016/j.cyto.2011.06.002. Epub 2011 Jul 6.
- Background: PubMed 19910332Sauvet F, Leftheriotis G, Gomez-Merino D, Langrume C, Drogou C, Van Beers P, Bourrilhon C, Florence G, Chennaoui M. Effect of acute sleep deprivation on vascular function in healthy subjects. J Appl Physiol (1985). 2010 Jan;108(1):68-75. doi: 10.1152/japplphysiol.00851.2009. Epub 2009 Nov 12.
- Background: PubMed 25127157Chennaoui M, Arnal PJ, Sauvet F, Leger D. Sleep and exercise: a reciprocal issue? Sleep Med Rev. 2015 Apr;20:59-72. doi: 10.1016/j.smrv.2014.06.008. Epub 2014 Jun 30.
- Background: PubMed 23760468Temesi J, Arnal PJ, Davranche K, Bonnefoy R, Levy P, Verges S, Millet GY. Does central fatigue explain reduced cycling after complete sleep deprivation? Med Sci Sports Exerc. 2013 Dec;45(12):2243-53. doi: 10.1249/MSS.0b013e31829ce379.
- Derived from this study: PubMed 31275098Rabat A, Arnal PJ, Monnard H, Erblang M, Van Beers P, Bougard C, Drogou C, Guillard M, Sauvet F, Leger D, Gomez-Merino D, Chennaoui M. Limited Benefit of Sleep Extension on Cognitive Deficits During Total Sleep Deprivation: Illustration With Two Executive Processes. Front Neurosci. 2019 Jun 19;13:591. doi: 10.3389/fnins.2019.00591. eCollection 2019.
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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.
Damien LEGER, MD, PhD study chair
Sleep center, Hotel Dieu Paris
Mounir CHENNAOUI, PhD study director
Institut de Recherche Biomedicale des Armees
Fabien SAUVET, MD, PhD principal investigator
Institut de Recherche Biomedicale des Armees
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Sleep deprivation in people with Sleep Deprivation, run by Institut de Recherche Biomedicale des Armees 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 8 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 2 Feb 2015. 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. 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?
Number of errors during PVT (n) (time frame: Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery). 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 NCT02352272, which also lists 6 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 2 Feb 2015.