Understanding sleep and brain development in children
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
This study is trying to understand how sleep affects brain development in children, including both healthy kids and those with developmental disorders, by collecting data on their sleep and brain activity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 244 (estimated) |
| Ages | 6 Months to 8 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 5 sites (Bethesda, Maryland and 4 other locations) |
| Trial ID | NCT04639830 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive database of sleep and neurodevelopmental data in infants and children, focusing on both healthy children and those with neurodevelopmental or neuropsychiatric disorders. Participants aged 6 months to 76 months will undergo neurodevelopmental testing, medical history assessments, and sleep EEG monitoring to capture brain activity during sleep. The study seeks to establish a standardized protocol for data acquisition that can inform on the neuro-maturational changes associated with sleep, ultimately addressing gaps in current knowledge. By facilitating data-sharing, the research aims to accelerate discoveries in the field of sleep and neurodevelopment.
Who should consider this trial
Good fit: Ideal candidates include children aged 6 months to 76 months, both healthy and those at risk for neurodevelopmental or neuropsychiatric disorders.
Not a fit: Patients who are older than 76 months or those with severe sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of sleep's role in brain development, potentially leading to improved interventions for children with neurodevelopmental disorders.
How similar studies have performed: Other studies have shown promise in understanding sleep's impact on neurodevelopment, but this approach aims to fill a specific data gap and is considered innovative.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 criteria for Group B (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: Screening assessment -The child meets any one or more of the following: 1. Enrolled in early intervention 2. Getting any targeted therapies 3. Neurodevelopmental or neuropsychiatric disorder 4. Failed ITC (ages 6 months - 24 months) 5. Failed the EI screener (\>24 months) 6. Child s first degree relative has been diagnosed with a neurodevelopmental disorder, such as autism or schizophrenia, or severe mental illness, such as major depressive disorder or bipolar disorder Comments: Screening assessment * Apnea hypopnea index (AHI) \<= 2/hour and no other evidence of sleep disordered breathing (SDB) EXCLUSION CRITERIA: Exclusion criteria for Group A (No known risk) -Meets inclusion criteria for Group B (known risk) Comments: Screening assessment -Any chronic or acute medical condition severe enough to interfere with overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, or ventilator dependency, or history of stroke or major neurologic insult. Taking any medications that is known to change sleep parameters within 2 weeks of screening polysomnogram. Comments: Screening assessment: Medical history -Any history of early intervention or diagnosis of a condition that put the child at risk for neurodevelopmental problems (e.g., genetic disorder, prenatal exposures, extreme prematurity) Screening assessment: Medical history Primary language other than English in the home Comments: Screening assessment -Apnea hypopnea index (AHI) \>2/hr or any other evidence of sleep disordered breathing (SDB) * The children of NIMH employees and staff may not take part. Comments: Screening assessment Exclusion criteria for Group B (Known risk) -Any chronic or acute medical condition severe enough to interfere with completion overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, or ventilator dependency. Comments: Screening assessment: Medical history -Primary language other than English in the home Comments: Screening assessment -Diagnosed with any of the following common genetic disorders associated with intellectual impairment: Fragile X, Down Syndrome, PraderWilli, Rett, Angelman, Phelan -McDermid, Smith-Lemli-Opitz, identified with a disorders of autonomic dysfunction that might compromise breathing function (examples include congenital central hypoventilation syndrome, familial dysautonmia), disorders of skeletal deformities (Marfan, achondroplasia), a neurogenic condition (spinal muscular atrophy, Duchenne muscular dystrophy, myotonic dystrophy), congenital myopathies or storage diseases (mucopolysaccharidosis, NCL, Wilsons, etc.) -The children of NIMH employees and staff may not take part. Comments: Screening assessment -Apnea hypopnea index \> 2/hr or any other evidence of sleep disordered breathing (SDB)
Where this trial is running
Bethesda, Maryland and 4 other locations
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- New York University - Langone Medical Center — New York, New York, United States (Not_yet_recruiting)
- Geisinger Medical Center — Danville, Pennsylvania, United States (Not_yet_recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Ashura W Buckley, M.D. — National Institute of Mental Health (NIMH)
- Study coordinator: ESP Study Team
- Email: espstudy@nih.gov
- Phone: (301) 480-7127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.