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

NCT04639830 | Recruiting

• 2 other identifiers: 20016620-M-0166
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 5

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

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sleep Spindle Activity

  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.

  ongoing

• Vineland Adaptive Behavior (VABS) Socialization growth scale.

  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.

  ongoing

Secondary Outcomes (1)

• Sleep Spindle Characteristics

  ongoing

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study Population: The total number of participants to be enrolled will be set at N = 244 (6 months to 8 years old) and will include the following: 1) Study 1: N = 90 with no known risk for neurodevelopmental disorders. These include children without identified neurodevelopmental problems who score within age-expected ranges on cognitive and behavioral screeners. 2) Study 2: N = 154 children at risk for or known to have selected neurodevelopmental/neuropsychiatric disorders, based on any one or more of the following criteria: a) Enrolled in early intervention b) Getting any targeted therapies c) Neurodevelopmental or neuropsychiatric disorder d) Failed Infant Toddler Checklist (ITC) (ages 6 months 24 months) e) Failed the Early Intervention (EI) screener (\>24 months)

You may qualify if:

• 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)
• 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:
• Enrolled in early intervention
• Getting any targeted therapies
• Neurodevelopmental or neuropsychiatric disorder
• Failed ITC (ages 6 months - 24 months)
• Failed the EI screener (\>24 months)

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (5)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

New York University - Langone Medical Center

New York, New York, 10016, United States

NOT YET RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 02115, United States

NOT YET RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

NOT YET RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Ashura W Buckley, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ESP Study Team

CONTACT

(301) 480-7127; espstudy@nih.gov

Ashura W Buckley, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: November 9, 2021
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-09-26

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: IPD and additional supporting information will become available in accordance with the NSRR s and NDAR's policies on public release of data. For other measures, it'll be up to 12 months after the project end date or at the time of acceptance of initial publication, whichever occurs first.
• Access Criteria: All data shared with NSRR will be coded; the key to the code will not be provided to collaborators but will remain at NIH. A subset of data shared with NSRR will be stripped of identity and be publicly available. NSRR will initially limit access to only ESP investigators; as the research progresses and with approval from the Steering Committee, de-identified data may be made available to individuals completing appropriate DAUAs.@@@@@@@@@@@@This study will comply with the NIH Genomic Data Sharing Policy, and samples and data for genomic analyses will be shared with Baylor College of Medicine and the NIMH Repository \& Genomics Resource (NRGR).@@@@@@@@@@@@Coded data from this study for all child participants will also be submitted to the NIH sponsored National Database for Autism Research, according to NDAR's data sharing policy (which may be found at http://ndar.nih.gov/ndarpublicweb/Documents/NDAR\ Policy.pdf).

Locations

US (5)