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 VolunteersHealthy 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
- Susan C Guttman(301) 451-9912
- Jeffrey H Duyn, Ph.D.(301) 594-7305
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | - |
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