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NCT04639830 · ClinicalTrials.gov registry record
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
A clinical trial of Healthy Children and Children With Neurodevelopmental Disorders, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- 244
- Enrollment target
- 5
- Study locations
NCT04639830: Recruiting study of Healthy Children and Children With Neurodevelopmental Disorders, sponsored by National Institute of Mental Health (NIMH).
NCT04639830 is a study of Healthy Children and Children With Neurodevelopmental Disorders that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 244 participants. The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04639830, a study of Healthy Children and Children With Neurodevelopmental Disorders, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- 244 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (5)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Massachusetts
- Boston Children's Hospital - Boston
New York
- New York University - Langone Medical Center - New York
Pennsylvania
- Geisinger Medical Center - Danville
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2027-04-15 |
What NCT04639830 shows while recruiting
NCT04639830 is an observational study that tracks outcomes without assigning an intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap.
The record links to 4 conditions, with Healthy Children appearing as the primary indexed condition, and to 0 interventions.
NCT04639830 lists 5 locations in 5 states (Maryland, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT04639830 about?
NCT04639830 is a clinical study titled "Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations". 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 ...
What is the current status of trial NCT04639830?
This trial is currently recruiting. The enrollment target is 244 participants. The study started on 2021-11-09. Estimated completion is 2027-04-15.
What conditions does trial NCT04639830 study?
This clinical trial studies the following conditions: Healthy Children, Children With Neurodevelopmental Disorders, Children With Neuropsychiatric Disorders, Children With Behavioral Syndromes.
Who is sponsoring clinical trial NCT04639830?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04639830 being conducted?
This trial has 5 study locations across Maryland, Massachusetts, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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