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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-8
SponsorNational Institute of Mental Health (NIMH)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

244 Participants
are grouped into 2 trial groups
Group A: Children with a known risk
Group B: Children with no known risk

Trial outcomes

Primary outcomes

1

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.

Time frame
ongoing
2

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.

Time frame
ongoing

Secondary outcomes

1

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).

Time frame
ongoing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.