About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The child is between 6 months & 76 months at the time of enrollment for the main study.
Enrolled in early intervention
Getting any targeted therapies
Neurodevelopmental or neuropsychiatric disorder
Disqualifiers
The children of NIMH employees and staff may not take part.
Trial 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)
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Sleep Spindle Characteristics
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).
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