Actively Recruiting

Age: 6Months - 8Years
All Genders
Healthy Volunteers
NCT04639830

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

Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-07

244

Participants Needed

5

Research Sites

283 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Months - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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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

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Research Team

E

ESP Study Team

CONTACT

A

Ashura W Buckley, M.D.

CONTACT

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

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