Sleep Study for Healthy and Neurodevelopmental Children
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Recruiting
Observational Study
Healthy ChildrenChildren With Neurodevelopmental DisordersChildren With Neuropsychiatric DisordersChildren With Behavioral Syndromes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 Months – 8
Sex
Any
Study type
Observational
Participants needed
244 (estimated)
Sponsor
National Institute of Mental Health (NIMH) · NIH
Who this trial is looking for
This trial is looking for children aged 6 months to 76 months, both healthy and those with neurodevelopmental or neuropsychiatric disorders. Participants will undergo tests and an overnight sleep study to help researchers gain insights into brain development and sleep patterns.
Are You a Good Fit for This Trial?
Rules you outFragile XDown SyndromePrader-WilliRett SyndromeAngelman SyndromePhelan-McDermid SyndromeSmith-Lemli-Opitz SyndromeCongenital central hypoventilation syndrome
You may be able to join if
I am between 6 months and 76 months old.
I have a referral for a sleep study.
A parent or guardian can give consent for me to participate.
You may not be able to join if
I have a chronic medical condition that affects my ability to sleep overnight.
I have a history of conditions putting me at risk for neurodevelopmental problems.
My primary language at home is not English.
I have sleep disordered breathing.
I am a child of NIMH employees or staff.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Eligib…
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.
Trial Locations
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Eligibility 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 assen…
* 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)
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