NCT02352272

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 19, 2015

Last Update Submit

January 27, 2015

Conditions

Sleep Deprivation

Keywords

sleep extensionattentionphysical performance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • median speed during PVT (s-1)

    Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery

  • number of micro sleep (n)

    Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery

  • Sleep latency (min)

    Every 3 hours, up to 24 hours of baseline, total sleep deprivation (TSD), and recovery

  • Muscular force (dyn)

    At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)

  • Response to Trans Magnetic Stimulation (%)

    At 10:00 on D1 (Baseline), D2 (TSD) and D3 (Recovery)

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: Total Sleep deprivation

Interventions

Total Sleep deprivationOTHER

Subject are submitted to 39 hours of continuous awaking in laboratory and a recovery night

Also known as: TSD
Habitual sleepSleep extension

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subject
  • voluntary

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital

Paris, 75003, France

Location

Related Publications (6)

  • 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.

    PMID: 19294951BACKGROUND

  • 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.

    PMID: 21737301BACKGROUND

  • 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.

    PMID: 19910332BACKGROUND

  • 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.

    PMID: 25127157BACKGROUND

  • 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.

    PMID: 23760468BACKGROUND

  • 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.

    PMID: 31275098DERIVED

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Damien LEGER, MD, PhD

    Sleep center, Hotel Dieu Paris

    STUDY CHAIR

  • Mounir CHENNAOUI, PhD

    Institut de Recherche Biomedicale des Armees

    STUDY DIRECTOR

  • Fabien SAUVET, MD, PhD

    Institut de Recherche Biomedicale des Armees

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Docteur

Study Record Dates

First Submitted

January 19, 2015

First Posted

February 2, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

FR(1)