Predicting Cognitive Resilience Against Sleep Loss
Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss
1 other identifier
interventional
48
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
July 27, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 16, 2014
June 1, 2014
1.2 years
July 23, 2012
June 13, 2014
Conditions
Keywords
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
EXPERIMENTALParticipants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory.
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.
Eligibility Criteria
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
- Mclean Hospitallead
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William D Killgore, PhD
Mclean Hospital
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