Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT02629107
Status
Recruiting

Conditions

  • Normal Physiology

Eligibility Criteria

Sex
ALL
Age
18 Years - 34 Years
Healthy Volunteers
Accepted

Study Details

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. ...

Key Dates

Start date
Jan 14, 2016
Status verified
Jun 2026
Primary completion
Dec 31, 2044
Completion
Dec 31, 2045

Study Design

Enrollment
2,378 participants (estimated)

Arms

  • Arm: Healthy Volunteers
    Healthy volunteers, age 18-34.

Primary Outcome Measure

The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from fMRI [ Time Frame: This outcome will be measured during Overnight Visit 1 and 2. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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