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Understanding Sleep and Brain Development in Children

This study is looking at how sleep and brain development are connected in children, both healthy children and those with neurodevelopmental or neuropsychiatric disorders. Researchers want to create a database of information to better understand these changes. They will measure sleep spindle activity (a type of brain wave during sleep) and social development using the Vineland Adaptive Behavior Scales (VABS). Children between 6 months and 8 years old can participate. The study aims to fill a gap in our knowledge about how sleep affects a child's developing brain. This is an observational study, meaning there are no interventions or treatments being tested.

Study design
This is an observational study with a planned enrollment of 244 participants. It is a multisite longitudinal study, meaning it will follow participants over time at several locations.
What's involved
Participants will have neurodevelopmental testing, a medical, psychiatric, and family history taken, and a physical and neurological exam. The record does not specify the number of visits or the duration of participation.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, Sleep Spindle Activity and Vineland Adaptive Behavior (VABS) Socialization growth scale, are measured "at ongoing," suggesting continuous or repeated measurements over time. The exact duration of follow-up is not specified.

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NCT04639830

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

Recruiting
Not specifiedAges 6–8Observational
National Institute of Mental Health (NIMH)
~244 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep Spindle Activity
Measured over ongoing
+1 more outcome measured

Conditions

Healthy Children
Children With Neurodevelopmental Disorders
Children With Neuropsychiatric Disorders
Children With Behavioral Syndromes

Explore related trials

Behavioral syndrome associated with physiological disturbance and physical factorsNeurodevelopmental abnormalityNeurodevelopmental DisorderNeurogenetic SyndromePsychiatric DisorderWell child

Where it's being run

5 sites across 5 states
Maryland1
Massachusetts1
New York1
Pennsylvania1
Texas1

Study leadership

  • Ashura W Buckley, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Mental Health (NIMH)

Who to contact

ESP Study Team
[email protected]
(301) 480-7127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Consent: Parent/caregiver (legal guardian) can give consent. NIH employees children are eligible to participate with the exception of NIMH employees children.
The child is between 6 months \& 76 months at the time of enrollment for the main study.
Apnea hypopnea index (AHI) \< 2/hour and no other evidence of sleep disordered breathing (SDB)
Consent: Parent/caregiver (legal guardian) can give consent. NIH employees children are eligible to participate with the exception of NIMH employees children.
The child is between 6 months \& 76 months at the time of enrollment for the main study.
The child meets any one or more of the following:
Apnea hypopnea index (AHI) \<= 2/hour and no other evidence of sleep disordered breathing (SDB)
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.
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)
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.

Exclusion

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.
Primary language other than English in the home
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.
Apnea hypopnea index \> 2/hr or any other evidence of sleep disordered breathing (SDB)

What this trial measures

  • Sleep Spindle Activityongoing

    The primary outcome measure in Study 1 is sleep spindle activity. Study 2 has an additional primary outcome, the Vineland Adaptive Behavior (VABS) Socialization growth scale.

  • Vineland Adaptive Behavior (VABS) Socialization growth scale.ongoing

    The primary outcome measure in Study 1 is sleep spindle activity. Study 2 has an additional primary outcome, the Vineland Adaptive Behavior (VABS) Socialization growth scale.