SleepNCT00117221
MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
An observational study of Sleep, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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, the brain continues to show spatial patterns of activity that resemble those during sensory and cognitive tasks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2005to 11 Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Sleep disorder (reported or detected);
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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, the brain continues to show spatial patterns of activity that resemble those during sensory and cognitive tasks. This phenomenon greatly affects the interpretation of neuroimaging studies based on positive emission tomography (PET) and fMRI, which rely on the contrast between brain activity during a task and activity during rest. In addition, resting state activity in itself may reveal information on the large-scale organization of neuronal networks and on functional abnormalities related to disease.
Participants should represent a broad cross section of the healthy adult population. Any neurologically and psychiatrically healthy male or nonpregnant female between 18 and 65 years old may be eligible.
Read more
Studies will be conducted in the In Vivo NMR Research Center. Concurrent electroencephalogram (EEG) and MRI studies will last between 1 and 2 hours. A typical study involves 15 minutes of anatomical MRI scanning followed by a 60-minute functional scan during which the subject relaxes with eyes closed and is encouraged to sleep while the fMRI/EEG are performed. Participants may be scanned 1 to 20 times. No more than 1 scan will be performed per day and no more than 20 scans will be performed within a year. During the last 5 to 10 minutes of the scan, the participant will open his or her eyes and actively participate in a visual stimulation or attention task. The participant's alertness will be measured by a behavioral (button-press) response. The visual stimuli (contrast reversing checkerboard displays, alternated with uniform grey fields) will be presented using the standard projection system available with the MRI scanner. The attention task will involve repeated visual presentation of groups of letters and digits; the participant will be asked about the correspondence between these groups.
Magnetoencephalogram (MEG) scans will be performed on some participants. The precise and undistorted signals available with MEG will be used to enhance the interpretation of alertness and sleep-related characteristics of the EEG signals, which can vary quite dramatically across subjects. In addition, the MEG signals will provide preliminary spatial localization of the sleep-dependent changes more precisely than is possible with EEG. MRI scanner noise will be simulated using tape recordings to allow comparison with the MRI/EEG data. MEG scans will last 45 minutes to 2 hours. At all times during any of the brain scans the participant will be able to communicate the MRI scientist or MEG/EEG technician and can ask to be removed from the device at any time.
The study will not have a direct benefit for participants. It may be help us learn more about brain function, which may lead to better treatments.
Read the 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 that in absence of external stimuli, the brain continues to show spatial patterns of activity that resemble the networks that activate during sensory and cognitive tasks. This phenomenon greatly affects the interpretation of neuroimaging studies based on PET and fMRI, since these rely on differential imaging in which activity during a task is contrasted against activity during rest. In addition, resting state activity in itself potentially contains unique information on the large scale organization of neuronal networks and reveals information about functional abnormalities related to disease processes.
Study Population. To avoid confounding factors related to disease processes, subjects for this study will be recruited from the normal adult population. In addition, subjects will be screened for sleep behavior, and subjects with abnormal sleep behavior will be excluded.
Design. The study is designed to facilitate MRI detection of cerebral metabolic differences between the sleep and awake states. Wakefulness and sleep, and the various stages will be classified in accordance with the EEG criteria, consistent with the guidelines of Rechtschaffen and Kales (Rechtschaffen, 1968). For this purpose, we will optimize the methodology for the concurrent acquisition of EEG and fMRI signals. Using concurrent EEG and state-of-the-art MRI, we plan to establish the precise spatial distribution of changes in brain activity that are associated with changes in the sleep/wake state and the various stages of sleep, specifically early sleep (stage 1 and 2). Secondly, we plan to investigate whether changes in regional brain metabolism as measured by MRI correlates with transitory EEG phenomena during sleep, including fluctuations in band-specific power, sleep spindles, and K-complexes.
Outcome Measure. As an outcome of this study, an atlas of activity clusters in normal subjects will be established, both during waking conditions, as well as during several sleep stages. Further outcomes will be spatial patterns of covariance with EEG band-specific power, spindles, and K-complexes. These data will serve as a baseline for comparison with activity patterns in patients.
- Conditions
- Sleep
- Keywords
- Magnetic Resonance Imaging, Functional Imaging, Cerebral Blood Flow, BOLD Effect, Sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2005 (estimated)
- Study start28 Jun 2005
- Study completion11 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Jeffrey H Duyn, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117221
- Sponsor's protocol ID
- 050179
- Other IDs
- 05-N-0179
- Status last verified
- 11 Feb 2014
- First submitted
- 2 Jul 2005
- Last updated
- 5 Dec 2019
- Results posted
- No
Publications
Bartels A, Zeki S. The chronoarchitecture of the human brain--natural viewing conditions reveal a time-based anatomy of the brain. Neuroimage. 2004 May;22(1):419-33. doi: 10.1016/j.neuroimage.2004.01.007.
PubMed 15110035Beckmann CF, Smith SM. Probabilistic independent component analysis for functional magnetic resonance imaging. IEEE Trans Med Imaging. 2004 Feb;23(2):137-52. doi: 10.1109/TMI.2003.822821.
PubMed 14964560Calhoun VD, Adali T, McGinty VB, Pekar JJ, Watson TD, Pearlson GD. fMRI activation in a visual-perception task: network of areas detected using the general linear model and independent components analysis. Neuroimage. 2001 Nov;14(5):1080-8. doi: 10.1006/nimg.2001.0921.
PubMed 11697939
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Measurement of Brain Metabolism Across the Sleep-Wake Cycle
- ClinicalTrials.gov ID
- NCT00117221
- Acronym / sponsor ID
- 050179
- Conditions
- Sleep
- Keywords
- Magnetic Resonance Imaging, Functional Imaging, Cerebral Blood Flow, BOLD Effect, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 28 Jun 2005
- Study completion
- 11 Feb 2014
- First posted
- 4 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, the brain continues to show spatial patterns of activity that resemble those during sensory and cognitive tasks. This phenomenon greatly affects the interpretation of neuroimaging studies based on positive emission tomography (PET) and fMRI, which rely on the contrast between brain activity during a task and activity during rest. In addition, resting state activity in itself may reveal information on the large-scale organization of neuronal networks and on functional abnormalities related to disease.
Participants should represent a broad cross section of the healthy adult population. Any neurologically and psychiatrically healthy male or nonpregnant female between 18 and 65 years old may be eligible.
Studies will be conducted in the In Vivo NMR Research Center. Concurrent electroencephalogram (EEG) and MRI studies will last between 1 and 2 hours. A typical study involves 15 minutes of anatomical MRI scanning followed by a 60-minute functional scan during which the subject relaxes with eyes closed and is encouraged to sleep while the fMRI/EEG are performed. Participants may be scanned 1 to 20 times. No more than 1 scan will be performed per day and no more than 20 scans will be performed within a year. During the last 5 to 10 minutes of the scan, the participant will open his or her eyes and actively participate in a visual stimulation or attention task. The participant's alertness will be measured by a behavioral (button-press) response. The visual stimuli (contrast reversing checkerboard displays, alternated with uniform grey fields) will be presented using the standard projection system available with the MRI scanner. The attention task will involve repeated visual presentation of groups of letters and digits; the participant will be asked about the correspondence between these groups.
Magnetoencephalogram (MEG) scans will be performed on some participants. The precise and undistorted signals available with MEG will be used to enhance the interpretation of alertness and sleep-related characteristics of the EEG signals, which can vary quite dramatically across subjects. In addition, the MEG signals will provide preliminary spatial localization of the sleep-dependent changes more precisely than is possible with EEG. MRI scanner noise will be simulated using tape recordings to allow comparison with the MRI/EEG data. MEG scans will last 45 minutes to 2 hours. At all times during any of the brain scans the participant will be able to communicate the MRI scientist or MEG/EEG technician and can ask to be removed from the device at any time.
The study will not have a direct benefit for participants. It may be help us learn more about brain function, which may lead to better treatments.
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 that in absence of external stimuli, the brain continues to show spatial patterns of activity that resemble the networks that activate during sensory and cognitive tasks. This phenomenon greatly affects the interpretation of neuroimaging studies based on PET and fMRI, since these rely on differential imaging in which activity during a task is contrasted against activity during rest. In addition, resting state activity in itself potentially contains unique information on the large scale organization of neuronal networks and reveals information about functional abnormalities related to disease processes.
Study Population. To avoid confounding factors related to disease processes, subjects for this study will be recruited from the normal adult population. In addition, subjects will be screened for sleep behavior, and subjects with abnormal sleep behavior will be excluded.
Design. The study is designed to facilitate MRI detection of cerebral metabolic differences between the sleep and awake states. Wakefulness and sleep, and the various stages will be classified in accordance with the EEG criteria, consistent with the guidelines of Rechtschaffen and Kales (Rechtschaffen, 1968). For this purpose, we will optimize the methodology for the concurrent acquisition of EEG and fMRI signals. Using concurrent EEG and state-of-the-art MRI, we plan to establish the precise spatial distribution of changes in brain activity that are associated with changes in the sleep/wake state and the various stages of sleep, specifically early sleep (stage 1 and 2). Secondly, we plan to investigate whether changes in regional brain metabolism as measured by MRI correlates with transitory EEG phenomena during sleep, including fluctuations in band-specific power, sleep spindles, and K-complexes.
Outcome Measure. As an outcome of this study, an atlas of activity clusters in normal subjects will be established, both during waking conditions, as well as during several sleep stages. Further outcomes will be spatial patterns of covariance with EEG band-specific power, spindles, and K-complexes. These data will serve as a baseline for comparison with activity patterns in patients.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- 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.
- Sleep disorder (reported or detected);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Background: PubMed 15110035Bartels A, Zeki S. The chronoarchitecture of the human brain--natural viewing conditions reveal a time-based anatomy of the brain. Neuroimage. 2004 May;22(1):419-33. doi: 10.1016/j.neuroimage.2004.01.007.
- Background: PubMed 14964560Beckmann CF, Smith SM. Probabilistic independent component analysis for functional magnetic resonance imaging. IEEE Trans Med Imaging. 2004 Feb;23(2):137-52. doi: 10.1109/TMI.2003.822821.
- Background: PubMed 11697939Calhoun VD, Adali T, McGinty VB, Pekar JJ, Watson TD, Pearlson GD. fMRI activation in a visual-perception task: network of areas detected using the general linear model and independent components analysis. Neuroimage. 2001 Nov;14(5):1080-8. doi: 10.1006/nimg.2001.0921.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Duyn, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117221, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.