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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-M-0166

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 6 mo
Max Age: 8 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Healthy Children;
Children with Neurodevelopmental Disorders;
Children with Neuropsychiatric Disorders;
Children with Behavioral Syndromes

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental Health

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.

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Eligibility

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:

a) Enrolled in early intervention

b) Getting any targeted therapies

c) Neurodevelopmental or neuropsychiatric disorder

d) Failed ITC (ages 6 months - 24 months)

e) Failed the EI screener (>24 months)

f) 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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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ashura W. Buckley, M.D.
National Institute of Mental Health (NIMH)
NIHBC 10 - CLINICAL CENTER BG RM 1C250
10 CENTER DR
BETHESDA MD 20892
(301) 496-5190
shu.buckley@nih.gov

ESP Study Team
National Institute of Mental Health (NIMH)

(301) 480-7127
espstudy@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04639830

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