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

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Total Sleep deprivation
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Deprivation focused on measuring sleep extension, attention, physical performance

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Sleep extension

Habitual sleep

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of errors during PVT (n)
number of errors (<100ms or > 500ms) during a10 min Psychomotor Vigilance test (PVT)

Secondary Outcome Measures

median speed during PVT (s-1)
median speed response during a10 min Psychomotor Vigilance test (PVT)
number of micro sleep (n)
number of micro sleep (> 5 sec) per hour during baseline, TSD and recovery
Sleep latency (min)
Sleep latency during multiple sleep latency test (MSLT)
Muscular force (dyn)
Muscular force developed by the subject
Response to Trans Magnetic Stimulation (%)
Effect of trans magnetic stimulation on Muscular force developed by the subject
Polysomnographic classification (N1, N2, N3, REM)
Evaluation of the duration of each sleep stages during the night before and after TSD

Full Information

First Posted
January 19, 2015
Last Updated
January 27, 2015
Sponsor
Institut de Recherche Biomedicale des Armees
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1. Study Identification

Unique Protocol Identification Number
NCT02352272
Brief Title
Benefits of Sleep Extension on Performances During Total Sleep Deprivation (BankingSleep)
Acronym
BankingSleep
Official Title
Benefits of Sleep Extension on Cognitive and Physical Performances During Baseline, Total Sleep Deprivation and Recovery (BankingSleep)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche Biomedicale des Armees

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep extension, attention, physical performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep extension
Arm Type
Experimental
Arm Description
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.
Arm Title
Habitual sleep
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Total Sleep deprivation
Other Intervention Name(s)
TSD
Intervention Description
Subject are submitted to 39 hours of continuous awaking in laboratory and a recovery night
Primary Outcome Measure Information:
Title
Number of errors during PVT (n)
Description
number of errors (<100ms or > 500ms) during a10 min Psychomotor Vigilance test (PVT)
Time Frame
Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Secondary Outcome Measure Information:
Title
median speed during PVT (s-1)
Description
median speed response during a10 min Psychomotor Vigilance test (PVT)
Time Frame
Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Title
number of micro sleep (n)
Description
number of micro sleep (> 5 sec) per hour during baseline, TSD and recovery
Time Frame
Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Title
Sleep latency (min)
Description
Sleep latency during multiple sleep latency test (MSLT)
Time Frame
Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery
Title
Muscular force (dyn)
Description
Muscular force developed by the subject
Time Frame
At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)
Title
Response to Trans Magnetic Stimulation (%)
Description
Effect of trans magnetic stimulation on Muscular force developed by the subject
Time Frame
At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)
Title
Polysomnographic classification (N1, N2, N3, REM)
Description
Evaluation of the duration of each sleep stages during the night before and after TSD
Time Frame
night during DA (Baseline) and D3 (Recovery)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien LEGER, MD, PhD
Organizational Affiliation
Sleep center, Hotel Dieu Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mounir CHENNAOUI, PhD
Organizational Affiliation
Institut de Recherche Biomedicale des Armees
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fabien SAUVET, MD, PhD
Organizational Affiliation
Institut de Recherche Biomedicale des Armees
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Paris
ZIP/Postal Code
75003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19294951
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. doi: 10.1093/sleep/32.3.311.
Results Reference
background
PubMed Identifier
21737301
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-alpha) levels in healthy men. Cytokine. 2011 Nov;56(2):318-24. doi: 10.1016/j.cyto.2011.06.002. Epub 2011 Jul 6.
Results Reference
background
PubMed Identifier
19910332
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.
Results Reference
background
PubMed Identifier
25127157
Citation
Chennaoui 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.
Results Reference
background
PubMed Identifier
23760468
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.
Results Reference
background
PubMed Identifier
31275098
Citation
Rabat 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.
Results Reference
derived

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

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