Recruiting

Observational Study

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT04639830

Conditions

Healthy Children

Children With Neurodevelopmental Disorders

Children With Neuropsychiatric Disorders

Children With Behavioral Syndromes

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Healthy Children

Children With Neurodevelopmental Disorders

Children With Neuropsychiatric Disorders

Children With Behavioral Syndromes

Study ID

NCT04639830

Start date

Nov 9, 2021

Status verified date

Sep 26, 2025

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 8

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA :

Inclusion criteria for Group A (No known risk)

-Consent: Parent/caregiver (legal guardian) can give consent. NIH employees children are eligible to participate with the exception of NIMH employees children.

Comments: Parents will provide consent for all minors. Verbal assent will be obtained from minors 7 years and older when applicable.

  • The child is between 6 months \& 76 months at the time of enrollment for the main study.

Comments: Prescreening assessment

-Apnea hypopnea index (AHI) < 2/hour and no other evidence of sleep disordered breathing (SDB)

Inclusion criteria for Group B (Known risk)

-Consent: Parent/caregiver (legal guardian) can give consent. NIH employees children are eligible to participate with the exception of NIMH employees children.

Comments: Parents will provide consent for all minors. Verbal assent will be obtained from minors 7 years and older when applicable.

-The child is between 6 months \& 76 months at the time of enrollment for the main study.

Comments: Screening assessment

-The child meets any one or more of the following:

1. Enrolled in early intervention
2. Getting any targeted therapies
3. Neurodevelopmental or neuropsychiatric disorder
4. Failed ITC (ages 6 months - 24 months)
5. Failed the EI screener (>24 months)
6. Child s first degree relative has been diagnosed with a neurodevelopmental disorder, such as autism or schizophrenia, or severe mental illness, such as major depressive disorder or bipolar disorder

Comments: Screening assessment
  • Apnea hypopnea index (AHI) <= 2/hour and no other evidence of sleep disordered breathing (SDB)

EXCLUSION CRITERIA:

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)

Study Design

Enrollment

244 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with a known risk

Children between 6 months and 76 months who are at risk for developing a neurodevelopmental disorder.

Children with no known risk

Children between 6 months and 76 months who don't have a risk for neurodevelopmental disorders.

Primary outcome measure

  • Sleep Spindle Activity [ Time Frame: ongoing ]
  • Vineland Adaptive Behavior (VABS) Socialization growth scale. [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

ESP Study Team

(301) 480-7127espstudy@nih.gov

Ashura W Buckley, M.D.

(301) 496-5190shu.buckley@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Aug 28, 2026

Last verified

Sep 26, 2025

Keywords

  • SLEEP STUDY
  • Healthy Children
  • Neurogenetic Syndrome
  • Abnormal Neurodevelopment
  • EEG
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-08-28.