Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations

Recruiting now

Conditions studied: Healthy Children, Children With Neurodevelopmental Disorders, Children With Neuropsychiatric Disorders, Children With Behavioral Syndromes

In brief

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 participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible.

Key facts

Study ID

NCT04639830

Run by

National Institute of Mental Health (NIMH)

People needed

244

Starts

2021-11-09

Expected to finish

2027-04-15

Last updated by the study team

2026-06-05

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion criteria for Group A (No known risk)
• Meets inclusion criteria for Group B (known risk)
• Comments: Screening assessment
• Any chronic or acute medical condition severe enough to interfere with overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, or ventilator dependency, or history of stroke or major neurologic insult. Taking any medications that is known to change sleep parameters within 2 weeks of screening polysomnogram.
• Comments: Screening assessment: Medical history
• Any history of early intervention or diagnosis of a condition that put the child at risk for neurodevelopmental problems (e.g., genetic disorder, prenatal exposures, extreme prematurity)
• Screening assessment: Medical history
• Primary language other than English in the home
• Comments: Screening assessment
• Apnea hypopnea index (AHI) >2/hr or any other evidence of sleep disordered breathing (SDB)
• The children of NIMH employees and staff may not take part.
• Comments: Screening assessment
• Exclusion criteria for Group B (Known risk)
• Any chronic or acute medical condition severe enough to interfere with completion overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, or ventilator dependency.
• Comments: Screening assessment: Medical history
• Primary language other than English in the home
• Comments: Screening assessment
• Diagnosed with any of the following common genetic disorders associated with intellectual impairment: Fragile X, Down Syndrome, PraderWilli, Rett, Angelman, Phelan -McDermid, Smith-Lemli-Opitz, identified with a disorders of autonomic dysfunction that might compromise breathing function (examples include congenital central hypoventilation syndrome, familial dysautonmia), disorders of skeletal deformities (Marfan, achondroplasia), a neurogenic condition (spinal muscular atrophy, Duchenne muscular dystrophy, myotonic dystrophy), congenital myopathies or storage diseases (mucopolysaccharidosis, NCL, Wilsons, etc.)
• The children of NIMH employees and staff may not take part.
• Comments: Screening assessment
• Apnea hypopnea index > 2/hr or any other evidence of sleep disordered breathing (SDB)

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States
• New York University - Langone Medical Center — New York, New York, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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