Status:
COMPLETED
MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Sleep
Eligibility:
All Genders
18-65 years
Brief Summary
This study will investigate the spatio-temporal characteristics of brain activity during sleep. Functional magnetic resonance imaging (fMRI) studies have shown that in the absence of external stimuli,...
Detailed Description
Objective. The objective of the proposed study is to investigate the spatio-temporal characteristics of brain activity during sleep. A number of recent fMRI (Ogawa, Lee et al. 1990) studies have shown...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Any neurologically and psychiatrically normal, male or female, healthy volunteer between 18 and 65 years old is in principle eligible for the study. Subjects must be capable of understanding the procedures and requirements of this study. Subjects must be willing to sign an informed consent document.
- EXCLUSION CRITERIA:
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; known absent acoustic reflex; ocular foreign body (e.g. metal shavings or insulin pump) and any pre-existing eye conditions. Subjects who underwent brain surgery, who have a neurological lesion, a psychiatric history or recurrent migraines that require medication will also be excluded from this study.
- To minimize potential confounds, subjects with abnormal sleep/wake patterns will be excluded. They should report no sleep problems or shift work, or medications that could impair sleep, no illegal drugs or tobacco. Subjects will be in good health as assessed by medical history, interview and physical exam.
- Subjects will be asked to:
- Refrain from alcohol and caffeinated products for 1 day prior to the study;
- Maintain their habitual bed times and wake-up times for 1 week prior to the study. A wrist-worn activity monitor (Actigraph\[R\], Precision Control Design, Inc., Fort Walton Beach, FL) may be used to confirm compliance with the latter instruction.
- Exclusion criteria include:
- Sleep disorder (reported or detected);
- Psychopathology, personal or first-degree relative. (They are likely to place the subject at risk for an adverse consequence related to the extended wakefulness portion of the study);
- Seizures or head injury with loss of consciousness greater than 5 minutes;
- Substance dependence (diagnosable);
- Smoking tobacco or psychotropic medications (currently);
- Caffeine consumption of 300 mg or 2 ounces of alcohol on a regular daily consumption;
- Cardiac, respiratory, or other medical condition that may affect cerebral metabolism.
Exclusion
Key Trial Info
Start Date :
June 28 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 11 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00117221
Start Date
June 28 2005
End Date
February 11 2014
Last Update
December 5 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892