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Protocol Details

An All-Night Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-N-0031

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 34

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

Sleep;
Functional Magnetic Resonance Imaging (fMRI);
Electroencephalogram (EEG)

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeffrey H. Duyn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Susan Fulton Guttman
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D704A
10 Center Drive
Bethesda, Maryland 20892
(301) 451-9912
fultons@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02629107

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