RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-09
Study Completion:2027-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04639830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * The children of NIMH employees and staff may not take part.

Contacts and Locations

Study Contact

ESP Study Team
CONTACT
(301) 480-7127
espstudy@nih.gov
Ashura W Buckley, M.D.
CONTACT
(301) 496-5190
shu.buckley@nih.gov

Principal Investigator

Ashura W Buckley, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
New York University - Langone Medical Center
New York, New York, 10016
United States
Geisinger Medical Center
Danville, Pennsylvania, 02115
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

  • Ashura W Buckley, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-09
Study Completion Date2027-04-15

Study Record Updates

Study Start Date2021-11-09
Study Completion Date2027-04-15

Terms related to this study

Keywords Provided by Researchers

  • SLEEP STUDY
  • Healthy Children
  • Neurogenetic Syndrome
  • Abnormal Neurodevelopment
  • EEG
  • Natural History

Additional Relevant MeSH Terms

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