NCT01651429

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

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

First Submitted

Initial submission to the registry

July 23, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

July 23, 2012

Last Update Submit

June 13, 2014

Conditions

Keywords

Sleep Deprivation

Outcome Measures

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.

    Session 2 of study (1 week after enrollment)

Secondary Outcomes (1)

  • Psychomotor Vigilance Task (PVT)

    At sleep deprivation session (2 weeks after enrollment)

Other Outcomes (1)

  • Karolinska Sleepiness Scale (KSS)

    At sleep deprivation session (2 weeks after enrollment)

Study Arms (1)

Sleep deprivation

EXPERIMENTAL

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

Behavioral: Sleep deprivation

Interventions

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.

Sleep deprivation

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

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

Study Officials

  • William D Killgore, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 27, 2012

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations