Predicting Cognitive Resilience Against Sleep Loss

Sleep Deprivation Clinical Trial

Official title:

Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651429
• Other study ID #: D12AP00241
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: June 13, 2014
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Karolinska Sleepiness Scale (KSS)	The KSS will be administered 17 throughout the overnight sleep deprivation session. The KSS provides a measure of subjective sleepiness.	At sleep deprivation session (2 weeks after enrollment)	No
Primary	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)	No
Secondary	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.	At sleep deprivation session (2 weeks after enrollment)	No