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Predicting Cognitive Resilience Against Sleep Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Killgore, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01651429
First received: July 23, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Sleep Deprivation
Behavioral: Sleep deprivation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS [ Time Frame: Session 2 of study (1 week after enrollment) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Psychomotor Vigilance Task (PVT) [ Time Frame: At sleep deprivation session (2 weeks after enrollment) ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Karolinska Sleepiness Scale (KSS) [ Time Frame: At sleep deprivation session (2 weeks after enrollment) ] [ Designated as safety issue: No ]
    The KSS will be administered 17 throughout the overnight sleep deprivation session. The KSS provides a measure of subjective sleepiness.


Enrollment: 48
Study Start Date: April 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep deprivation
Participants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory.
Behavioral: Sleep 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651429

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: William D Killgore, PhD Mclean Hospital
  More Information

No publications provided

Responsible Party: William Killgore, Assistant Professor, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01651429     History of Changes
Other Study ID Numbers: D12AP00241
Study First Received: July 23, 2012
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
Sleep Deprivation

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders

ClinicalTrials.gov processed this record on November 20, 2014