Condition: Healthy Children · Children With Neurodevelopmental Disorders · Children With Neuropsychiatric Disorders · Sponsor: National Institute of Mental Health (NIMH)
Background: During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more. Objective: To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children. Eligibility: Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study. Design: Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample. Some participants will have 1 study visit that lasts 2 days. Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years. Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study. Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on…
This description comes directly from the study's public registry record.
ESP Study Team · (301) 480-7127 · espstudy@nih.gov
Ashura W Buckley, M.D. · (301) 496-5190 · shu.buckley@nih.gov
Always discuss trial participation with your own doctor first.
| National Institutes of Health Clinical Center | Bethesda, Maryland, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Not Yet Recruiting |
| New York University - Langone Medical Center | New York, New York, United States | Not Yet Recruiting |
| Geisinger Medical Center | Danville, Pennsylvania, United States | Not Yet Recruiting |
| Texas Children's Hospital | Houston, Texas, United States | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT04639830