Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
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|ClinicalTrials.gov Identifier: NCT02629107|
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : March 20, 2019
An electroencephalogram (EEG) measures the brain s electrical activity. EEG shows that the louder the sound needed to wake a person, the deeper the person s sleep. Researchers are using functional magnetic resonance imaging (fMRI) to study people during sleep so they can view brain activity in 3D. But they still need to correlate fMRI with sound thresholds, like the EEG.
To measure brain activity during sleep using fMRI and EEG.
Healthy people ages 18 34 who can sleep on their back for several hours.
Participants will be screened online about their sleep and general health.
At a screening visit, participants will have:
MRI scan. A strong magnetic field and radio waves take pictures of the brain. Participants will lie down on a bed that slides into the scanner, which is shaped like a cylinder.
Participants will wear an actigraph on their wrist that records their motor activity.
Participants will follow a 2-week routine. This includes regular in-to-bed and out-of-bed times and limits on alcohol, caffeine, and nicotine.
At the 3-day inpatient visit, participants will have:
Female subjects will have a urine pregnancy test.
fMRI. A coil will be placed over the head. Participants will do tasks shown on a computer screen inside the scanner.
EEG. Small electrodes on the scalp will record brain waves while sleeping or doing a task in the scanner.
Participants will be asked to try to sleep while researchers collect fMRI and EEG data. Participants eyes will be monitored with a video camera. Headphones will deliver sounds to wake them up throughout the night.
|Condition or disease|
Electroencephalography is generally considered the gold standard for defining sleep, but, in fact, sleep is a behavior and is defined by widely accepted behavioral characteristics like auditory arousal threshold. Electroencephalography merely became a surrogate for the behavioral definition when, in the first electroencephalographic sleep studies, researchers discovered a strong correlation between electroencephalographic slow waves and auditory arousal thresholds. With the advent of functional magnetic resonance imaging, one would expect the first sleep studies that used this new measure would have been designed to correlate it with auditory arousal threshold. However, these studies have never been conducted. This protocol will fill this gap in the literature. We hypothesize that undiscovered patterns of brain activity or functional connectivity exist during sleep and that an approach that defines sleep behaviorally will expose these patterns.
The subject group in this study will be young, healthy individuals with excellent sleep health. Choosing this subject group will maximize the probability that subjects will sleep during all-night functional magnetic resonance imaging. Our target number of completers
is 12 for the pilot study and 43 for the main study.
After a one-week home-monitoring period that includes a regular in-to-bed and out-of bed time, subjects will undergo two all-night functional magnetic resonance imaging sleep studies separated by a one-week washout period with continued home
monitoring.. The first night will serve as an adaptation night, which is known to reduce the sleep alterations that accompany sleeping in a laboratory environment. We will measure sleep depth behaviorally by arousing subjects with auditory stimuli that progressively increase in intensity. This procedure will be performed approximately eight times per night. The timing of the arousals will be distributed randomly across the night.
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from functional magnetic resonance imaging.
|Study Type :||Observational|
|Estimated Enrollment :||610 participants|
|Official Title:||An All-Night Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli|
|Study Start Date :||December 10, 2015|
|Estimated Primary Completion Date :||February 27, 2020|
|Estimated Study Completion Date :||August 22, 2024|
- The primary outcome measures are auditory arousal thresholds and the preceding brain activity and functional connectivity derived from fMRI. These measures will be analyzed as individual data points. Auditory arousal thresholds will allow us t... [ Time Frame: 2 nights ]
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): NCT02629107
|Contact: Susan Fulton Guttman||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Jeffrey H Duyn, Ph.D.||National Institute of Neurological Disorders and Stroke (NINDS)|