NCT02629107 · National Institute of Neurological Disorders and Stroke (NINDS)
Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
What this study is about
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.
View original scientific description
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. ...
Primary outcome measures
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.
Auditory arousal thresholds will allow us to define sleep depth behaviorally.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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;
- work night shifts;
- have metal in your body such as pacemakers, metal prostheses, or aneurysm clips that would make MRI scanning unsafe;
- are pregnant or nursing;
- drink too much caffeine (6 or more cups of coffee per day or 10 or more cups of caffeinated soda per day);
- use too much alcohol (15 or more alcoholic beverages per week for men and 8 or more alcoholic beverages per week for women);
- use too much nicotine (nicotine use within 30 minutes of waking);
- are afraid of enclosed spaces;
- have known hearing problems;
- regularly use a prescription or over-the-counter drug to help you sleep or stay awake;
- are an employee, contractor, or volunteer of the Laboratory of Functional and Molecular Imaging in the National Institute of Neurological Disorders and Stroke.
Where
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations