Predicting Cognitive Resilience Against Sleep Loss
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ClinicalTrials.gov Identifier: NCT01651429 |
Recruitment Status
:
Completed
First Posted
: July 27, 2012
Last Update Posted
: June 16, 2014
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Condition or disease | Intervention/treatment | Phase |
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Sleep Deprivation | Behavioral: Sleep deprivation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Multimodal Neuroimaging to Predict Cognitive Resilience Against Sleep Loss |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Sleep deprivation
Participants will undergo 29 hours of sleep deprivation, 17 of which will be spent in the laboratory.
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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.
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- Differences in the medial prefrontal cortex (MPFC) as measured by fMRI, DTI, and MRS [ Time Frame: Session 2 of study (1 week after enrollment) ]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.
- Psychomotor Vigilance Task (PVT) [ Time Frame: At sleep deprivation session (2 weeks after enrollment) ]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.
- Karolinska Sleepiness Scale (KSS) [ Time Frame: At sleep deprivation session (2 weeks after enrollment) ]The KSS will be administered 17 throughout the overnight sleep deprivation session. The KSS provides a measure of subjective sleepiness.

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651429
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 |
Principal Investigator: | William D Killgore, PhD | Mclean Hospital |
Responsible Party: | William Killgore, Assistant Professor, Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT01651429 History of Changes |
Other Study ID Numbers: |
D12AP00241 |
First Posted: | July 27, 2012 Key Record Dates |
Last Update Posted: | June 16, 2014 |
Last Verified: | June 2014 |
Keywords provided by William Killgore, Mclean Hospital:
Sleep Deprivation |
Additional relevant MeSH terms:
Sleep Deprivation Dyssomnias Sleep Wake Disorders Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders |