Actively Recruiting
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Led by National Institute of Mental Health (NIMH) · Updated on 2026-06-05
244
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers aim to fill a knowledge gap by studying sleep and brain development in infants and children aged 6 months to 8 years. This observational study focuses on how sleep patterns relate to neurodevelopmental and neuropsychiatric disorders, including autism and related conditions. The goal is to build a detailed database using sleep EEG to track brain function changes and predict behavioral and cognitive outcomes over time. Participants are divided into two groups: children at risk for neurodevelopmental disorders and children without known risk. They will undergo neurodevelopmental testing, medical and psychiatric history reviews, physical and neurological exams, interviews, and surveys. Some children will have a single 2-day visit, while others will have up to four 2-day visits spaced 8 months to 1 year apart over two years. Each child will participate in an overnight sleep study with electrodes placed to record brain activity during sleep. During the study, children may also have a brief daytime EEG to help calibrate the overnight sleep recording. Researchers will collect biological samples like cheek swabs or blood and monitor sleep using sensors and a protective gauze cap for the electrodes. The study will measure sleep spindle activity and social behavior development, among other sleep and neurodevelopmental features, to understand brain maturation and its links to behavior and disorders. Participation may last up to two years, with ongoing assessments to track development.
CONDITIONS
Brief Title
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal guardian can provide consent; verbal assent from children 7 years and older when applicable
- Child is between 6 months and 76 months old at enrollment
- For children without known risk: Apnea hypopnea index (AHI) less than 2/hour and no evidence of sleep-disordered breathing
- For children with known risk: Meets one or more criteria such as enrollment in early intervention, receiving targeted therapies, diagnosis of a neurodevelopmental or neuropsychiatric disorder, or failed developmental screeners
- English is the primary language spoken in the home
You will not qualify if you...
- For children without known risk: Meets criteria for known risk group
- Chronic or acute medical conditions that interfere with overnight sleep study, such as tracheotomy, uncontrolled seizures, ventilator dependency, or major neurologic insult
- Use of medications known to alter sleep within 2 weeks before screening
- History of early intervention or diagnosis indicating risk for neurodevelopmental problems
- Primary language other than English spoken at home
- Apnea hypopnea index greater than 2/hour or other evidence of sleep-disordered breathing
- Diagnosed with genetic disorders associated with intellectual impairment such as Fragile X, Down Syndrome, Prader-Willi, Rett, Angelman, or others
- Children of NIMH employees and staff are not eligible to participate
- For children with known risk: Same medical and language exclusions as above
- Diagnosed with disorders affecting breathing function, skeletal deformities, neurogenic conditions, congenital myopathies, or storage diseases that could affect study participation
- Apnea hypopnea index greater than 2/hour or evidence of sleep-disordered breathing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on individual assessments
Participants undergo sleep EEG studies and other assessments to characterize sleep patterns and neurodevelopmental status.
1 to 2 visits depending on age and risk group
Duration - Up to several years with periodic assessments
Participants are followed over time with repeated sleep and behavioral assessments to track neurodevelopmental trajectories.
Repeated visits scheduled longitudinally according to study protocol
Trial Site Locations
Total: 5 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
New York University - Langone Medical Center
New York, New York, United States, 10016
Not Yet Recruiting
4
Geisinger Medical Center
Danville, Pennsylvania, United States, 02115
Not Yet Recruiting
5
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
E
ESP Study Team
A
Ashura W Buckley, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here