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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

6 Months - 8 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Nov 9, 2021

Status verified

Sep 2025

Primary completion

Apr 15, 2027

Completion

Apr 15, 2027

Study Design

Enrollment

244 participants (estimated)

Arms

• Arm: Children with a known risk
  Children between 6 months and 76 months who are at risk for developing a neurodevelopmental disorder.
• Arm: Children with no known risk
  Children between 6 months and 76 months who don't have a risk for neurodevelopmental disorders.

Primary Outcome Measure

Sleep Spindle Activity [ Time Frame: ongoing ]

Central Contacts

• ESP Study Team
  (301) 480-7127
  [email protected]
• Ashura W Buckley, M.D.
  (301) 496-5190
  [email protected]

Locations (5)

Find similar trials in Bethesda, MD

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