Back to resultsPredicting Cognitive Resilience Against Sleep Loss
Primary Purpose
Sleep Deprivation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep deprivation
Sponsored by
About this trial
This is an interventional screening trial for Sleep Deprivation focused on measuring Sleep Deprivation
Eligibility 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
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sleep deprivation
Arm Description
Participants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651429
Brief Title
Predicting Cognitive Resilience Against Sleep Loss
Official Title
Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
Sleep Deprivation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep deprivation
Arm Type
Experimental
Arm Description
Participants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory.
Intervention Type
Behavioral
Intervention Name(s)
Sleep deprivation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS
Description
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 Outcome Measure Information:
Title
Psychomotor Vigilance Task (PVT)
Description
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 Pre-specified Outcome Measures:
Title
Karolinska Sleepiness Scale (KSS)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Killgore, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
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Predicting Cognitive Resilience Against Sleep Loss
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