Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
National Institute of Mental Health (NIMH)
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. ...
Description
This is a multisite longitudinal study with NIH as the lead site. The other sites: Texas Children s Hospital, Boston Children s Hospital, Geisinger Medical Center, NYU and the NHLBI- supported, area specific repository, National Sleep Research Repository (NSRR). This study will address the data gap established by two NIMH sponsored intramural/extramural workshops (2017 and 2018) in the field of sleep and neurodevelopment by establishing a standardized, reliable protocol for real time acquisition of research data on the normal and abnormal neuro-maturational changes that are sleep-dependent. It…
Eligibility
- Age range
- 0–8 years
- Sex
- All
- Healthy volunteers
- Yes
* 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…
Locations (5)
- National Institutes of Health Clinical CenterBethesda, Maryland
- Boston Children's HospitalBoston, Massachusetts
- New York University - Langone Medical CenterNew York, New York
- Geisinger Medical CenterDanville, Pennsylvania
- Texas Children's HospitalHouston, Texas