Benefits of Sleep Extension on Performances During Total Sleep Deprivation (BankingSleep)

Sleep Deprivation Clinical Trial

— BankingSleep  

Official title:

Benefits of Sleep Extension on Cognitive and Physical Performances During Baseline, Total Sleep Deprivation and Recovery (BankingSleep)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352272
• Other study ID #: 14ca703op1
• Secondary ID: 2013-A01403-42
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 27, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Institut de Recherche Biomedicale des Armees
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: CPP Ile de France 1 (Ethic commity for subject protection)
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy subject

• voluntary

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Total Sleep deprivation
Subject are submitted to 39 hours of continuous awaking in laboratory and a recovery night

Locations

Country	Name	City	State
France	Hotel Dieu Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherche Biomedicale des Armees

Country where clinical trial is conducted

France, 

References & Publications (5)

Chennaoui M, Arnal PJ, Sauvet F, Léger 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. Review. — View Citation

Chennaoui 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-a) levels in healthy men. Cytokine. 2011 Nov;56(2):318-24. doi: 10.1016/j.cyto.2011.06.002. Epub 2011 Jul 6. — View Citation

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. — View Citation

Sauvet 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. — View Citation

Temesi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of errors during PVT (n)	number of errors (<100ms or > 500ms) during a10 min Psychomotor Vigilance test (PVT)	Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery	No
Secondary	median speed during PVT (s-1)	median speed response during a10 min Psychomotor Vigilance test (PVT)	Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery	No
Secondary	number of micro sleep (n)	number of micro sleep (> 5 sec) per hour during baseline, TSD and recovery	Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery	No
Secondary	Sleep latency (min)	Sleep latency during multiple sleep latency test (MSLT)	Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery	No
Secondary	Muscular force (dyn)	Muscular force developed by the subject	At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)	No
Secondary	Response to Trans Magnetic Stimulation (%)	Effect of trans magnetic stimulation on Muscular force developed by the subject	At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)	No
Secondary	Polysomnographic classification (N1, N2, N3, REM)	Evaluation of the duration of each sleep stages during the night before and after TSD	night during DA (Baseline) and D3 (Recovery)	No