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CompletedNCT01651429Updated Jun 16, 2014

Predicting Cognitive Resilience Against Sleep Loss

An interventional study of Sleep deprivation in Sleep Deprivation, sponsored by Mclean Hospital. Completed at 1 site in United States. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-16.

Sponsored by Mclean Hospital · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
All
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Study summary

Resilience is the ability to cope effectively and adapt to a wide range of stressful environmental challenges. Sleep loss has been shown to reduce activity in the brain regions responsible for resilience. The ability to resist the effects of sleep loss appears to be a stable, trait-like quality. This study will attempt to predict individuals' trait-resistance to sleep loss based on their neurobiology.

Read the detailed description

Resilience, the ability to cope effectively and adapt to a wide range of stressful environmental challenges, appears to be mediated extensively by the medial prefrontal cortex (MPFC). Sleep deprivation has been shown to reduce metabolic activity throughout the brain, particularly the MPFC. The ability to resist the effects of sleep loss appears to be a stable, trait-like phenomenon that is consistent across situations, suggesting that it may reflect an enduring quality of the underlying neurobiological system. The present study aims to identify the neural basis of resilience and effectively discriminate resistant from vulnerable individuals during an overnight sleep deprivation session. Specifically, the primary aims of this research are 1) to further our understanding of the role of the MPFC in resilience and 2) to develop a statistical prediction algorithm based on multimodal neuroimaging that will reliably discriminate between individuals who are resilient versus vulnerable to the cognitive impairing effects of sleep loss.

02

Conditions studied

  • Sleep Deprivation

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Keywords

  • Sleep Deprivation
03

In context

Sleep Deprivation

300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.

This study's enrollment of 48 is close to the median of 45 across 248 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 20-45 years
  • Right handedness as assessed by the Edinburgh Handedness Inventory
  • For women: regular menstrual cycles (duration between 25 and 35 days with no more than 3 day variation between cycle)

Exclusion criteria

Exclusion Criteria:

  • History of head injury with loss of consciousness or post-traumatic amnesia, or major neurological illness
  • Medical or neurologic condition that would confound interpretation of results, including alcohol or drug abuse/dependence in the past 6 months, neurological disorders including any history of seizures
  • History of cardiac problems
  • History of major depressive disorder or anxiety disorder
  • Lifetime history of psychotic disorder, including bipolar disorder, schizophrenia, or obsessive compulsive disorder
  • Other DSM-IV diagnosis that could affect interpretation of results
  • Mixed or left handedness
  • Abnormal visual acuity that cannot be corrected by contact lenses
  • Daily caffeine use exceeding 400 mg per day
  • History of smoking or tobacco use in the past year
  • Metal within the body, pregnancy, or other contraindication for MRI procedures
  • Use of drugs or medications that could affect functional neuroimaging results (e.g., fluoxetine, beta-blockers)
  • Psychotropic medication use within the past 6 weeks
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Sleep deprivation

    Participants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory.

    Behavioral: Sleep deprivation

Interventions

  • BehavioralSleep deprivation

    Participants will undergo 29 hours of sleep deprivation. They will wake up at 7:00 am on the day of the study and remain awake in the laboratory until 12:00 pm the next day.

06

What researchers measure

Primary outcomes

  1. Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS

    It is hypothesized that, relative to vulnerable individuals, those who are highly resistant to the adverse effects of sleep loss on cognition will show: 1) increased gray matter volume in the MPFC, 2) greater white matter integrity as indicated by the Diffusion Tensor Imaging measure of fractional anisotropy (FA) values in the MPFC, 3) greater functional activation in MPFC during cognitively demanding tasks, 4) greater functional connectivity between MPFC and alerting regions of the midbrain and thalamus; and 5) different ratios of GABA and glutamate within the MPFC.

    Time frame: Session 2 of study (1 week after enrollment)

Secondary outcomes

  1. Psychomotor Vigilance Task (PVT)

    The PVT will be administered 17 throughout the overnight sleep deprivation session. PVT performance measures participants' alertness and objective resilience to sleep deprivation. PVT performance will be used as a measure to retrospectively assign participants into sleep loss-resistant and sleep loss-vulnerable groups.

    Time frame: At sleep deprivation session (2 weeks after enrollment)

Other outcomes

  1. Karolinska Sleepiness Scale (KSS)

    The KSS will be administered 17 throughout the overnight sleep deprivation session. The KSS provides a measure of subjective sleepiness.

    Time frame: At sleep deprivation session (2 weeks after enrollment)

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Study locations

1 site
  • McLean Hospital
    Belmont, Massachusetts 02478, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01651429
Lead sponsor
Mclean Hospital
Responsible party
William Killgore (Assistant Professor, Mclean Hospital) — Principal investigator
First posted
Jul 27, 2012
Start date
Apr 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jun 16, 2014

Study contacts

William D Killgore, PhD
principal investigator · Mclean Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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