Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-34
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

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.

...

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

able to give informed consent;

in good general heath;

between the ages of 18 and 34 years;

able to sleep on your back for several hours (with breaks).

Disqualifiers

have a medical condition like diabetes or uncontrolled hypertension;

have a psychiatric or neurologic condition like depression or stroke;

have ever had a seizure;

have a sleep disorder like insomnia or sleep apnea;

Trial population

Volunteers will be recruited from the community and NIH employees.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,378 Participants
are grouped into 1 trial group
Group A: Healthy Volunteers

Trial outcomes

Primary outcomes

1

The data generated will be auditory arousal thresholds and the preceding brain activity and functional connectivity derived from fMRI

Auditory arousal thresholds will allow us to define sleep depth behaviorally.

Time frame
This outcome will be measured during Overnight Visit 1 and 2.

Secondary outcomes

Other outcomes

Sponsors and contacts

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