Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
NCT ID: NCT04639830
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
244 participants
OBSERVATIONAL
2021-11-09
2027-04-15
Brief Summary
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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.
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Detailed Description
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While specific differences in the architecture of sleep (e.g., stages, movement abnormalities, cyclicity, spindles and other bio-signatures that reflect anatomical microstructure) may be used to differentiate neurodevelopmental cohorts, the enormous potential of this proposed database lies in the ability to track functional connectivity (coherence) during sleep in the developing brain in a longitudinal, prospective manner, thereby establishing both normal and aberrant trajectories. Predictive relationships can be determined once these trajectories are established. Coherence studies would allow for the potential recreation of neural circuits that sub-serve various brain functions, such as language and attention. Tracking the trajectory of neural development prior to and during the developmental window when these circuits are maturing will allow for an understanding of best potential windows of intervention.
Objectives: The long term, primary objective of this protocol is to evaluate the degree to which the development and maturation of sleep patterns, with an emphasis on the relationship of those patterns to electrophysiologic signals, can predict cognitive and behavioral outcomes. Assessing participants over time will allow researchers to gain additional knowledge about the role of abnormal sleep, measured both clinically and by polysomnogram, in various childhood neuropsychiatric/ neurodevelopmental disorders and behavioral syndromes.
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:
1. Enrolled in early intervention
2. Getting any targeted therapies
3. Neurodevelopmental or neuropsychiatric disorder
4. Failed Infant Toddler Checklist (ITC) (ages 6 months 24 months)
5. Failed the Early Intervention (EI) screener (\>24 months)
Design: Study 1 (N = 90) and Study 2 (N = 154) use the same accelerated longitudinal design.
Outcome Measures: 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. In both studies, secondary outcome measures will include:other characteristics of sleep spindles, sleep rhythms (ultradian, circadian), macroarchitecture (stages and latencies), microarchitecture (measures of connectivity and network analyses).
Predictors include other neurodevelopmental variables, including other domain scores from the Vineland, IQ, and quantitative measurement of behavioral problems and social communicative development.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with a known risk
Children between 6 months and 76 months who are at risk for developing a neurodevelopmental disorder.
No interventions assigned to this group
Children with no known risk
Children between 6 months and 76 months who don't have a risk for neurodevelopmental disorders.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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:
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)
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
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)
6 Months
8 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Responsible Party
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Principal Investigators
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Ashura W Buckley, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
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
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
Kiran Maski, M.D.
Role: primary
Alcibiades Rodriguez, M.D.
Role: primary
Anne Morse, D.O.
Role: primary
Mirjana Maletic-Savatic
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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200166
Identifier Type: -
Identifier Source: org_study_id
20-M-0166
Identifier Type: -
Identifier Source: secondary_id