Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02629107
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2015-12-10
Brief Title:
Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An All-Night Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
Status:
RECRUITING
Status Verified Date:
2024-08-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
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
Objective
To measure brain activity during sleep using fMRI and EEG
Eligibility
Healthy people ages 18 34 who can sleep on their back for several hours
Design
Participants will be screened online about their sleep and general health
At a screening visit participants will have
Physical exam
Hearing exam
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
During the overnight visits 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
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
Objective
To measure brain activity during sleep using fMRI and EEG
Eligibility
Healthy people ages 18 34 who can sleep on their back for several hours
Design
Participants will be screened online about their sleep and general health
At a screening visit participants will have
Physical exam
Hearing exam
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
During the overnight visits 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
Detailed Description:
Objective
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
Study Population
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 was 12 for the pilot study and is 43 for the main study
Design
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
Data Generated
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from functional magnetic resonance imaging
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
Study Population
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 was 12 for the pilot study and is 43 for the main study
Design
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
Data Generated
The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from functional magnetic resonance imaging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16-N-0031 | None | None | None |