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Scientists track Kids' sleep to unlock brain growth secrets

NCT ID NCT04639830

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 6 times

Summary

This study aims to learn how sleep changes as children's brains grow, by collecting sleep and development data from healthy children and those with conditions like autism or ADHD. About 244 children ages 6 months to 8 years will have overnight sleep studies, developmental tests, and medical exams. The goal is to create a database to better understand sleep's role in brain maturation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study Population: The total number of participants to be enrolled will be set at N = 244 (6 months to 8 years old) and will include the following: 1) Study 1: N = 90 with no known risk for neurodevelopmental disorders. These include children without identified neurodevelopmental problems who score within age-expected ranges on cognitive and behavioral screeners. 2) Study 2: N = 154 children at risk for or known to have selected neurodevelopmental/neuropsychiatric disorders, based on any one or more of the following criteria: a) Enrolled in early intervention b) Getting any targeted therapies c) Neurodevelopmental or neuropsychiatric disorder d) Failed Infant Toddler Checklist (ITC) (ages 6 months 24 months) e) Failed the Early Intervention (EI) screener (\>24 months)

Ages

6 months to 8 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Geisinger Medical Center

    NOT_YET_RECRUITING

    Danville, Pennsylvania, 02115, United States

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • New York University - Langone Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Texas Children's Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

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