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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.

At the 3-day inpatient visit, participants will have:

Hearing exams.

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
Normal Physiology

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

is 12 for the pilot study and 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.


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Study Type : Observational
Estimated Enrollment : 610 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. able to give informed consent;
    2. in good general heath;
    3. between the ages of 18 and 34 years;
    4. able to sleep on your back for several hours (with breaks).

EXCLUSION CRITERIA:

  1. have a medical condition like diabetes or uncontrolled hypertension;
  2. have a psychiatric or neurologic condition like depression or stroke;
  3. have ever had a seizure;
  4. have a sleep disorder like insomnia or sleep apnea;
  5. work night shifts;
  6. have metal in your body such as pacemakers, metal prostheses, or aneurysm clips that would make MRI scanning unsafe;
  7. are pregnant or nursing;
  8. drink too much caffeine (6 or more cups of coffee per day or 10 or more cups of caffeinated soda per day);
  9. use too much alcohol (15 or more alcoholic beverages per week for men and 8 or more alcoholic beverages per week for women);
  10. use too much nicotine (nicotine use within 30 minutes of waking);
  11. are afraid of enclosed spaces;
  12. have known hearing problems;
  13. regularly use a prescription or over-the-counter drug to help you sleep or stay awake;
  14. are an employee, contractor, or volunteer of the Laboratory of Functional and Molecular Imaging in the National Institute of Neurological Disorders and Stroke.

Information from the National Library of Medicine

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


Contacts
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Contact: Susan Fulton Guttman (301) 451-9912 fultons@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Jeffrey H Duyn, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02629107     History of Changes
Other Study ID Numbers: 160031
16-N-0031
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: December 19, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Sleep
Functional Magnetic Resonance Imaging (fMRI)
Electroencephalogram (EEG)