NCT02629107 Functional Magnetic Resonance Imaging Sleep Study With Auditory Stimuli
| NCT ID | NCT02629107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Normal Physiology |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,378 participants |
| Start Date | 2016-01-14 |
| Primary Completion | 2044-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,378 participants in total. It began in 2016-01-14 with a primary completion date of 2044-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
* 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.
Contact & Investigator
Jeffrey H Duyn, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT02629107 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 34 Years, studying Normal Physiology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02629107 currently recruiting?
Yes, NCT02629107 is actively recruiting participants. Contact the research team at fultons@mail.nih.gov for enrollment information.
Where is the NCT02629107 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02629107 clinical trial?
NCT02629107 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Jeffrey H Duyn, Ph.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 2,378 participants.