New York, NYNCT04639830Now EnrollingIRB Ready

Healthy Children Clinical Trial in New York, NY

Access cutting-edge healthy children treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Mental Health (NIMH)

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Expert Care in New York

Access healthy children specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related healthy children treatment provided free

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Check if you qualify for this healthy children clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Healthy Children Study in New York

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.

Sponsor: National Institute of Mental Health (NIMH)

Who Can Participate

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:
Enrolled in early intervention
Getting any targeted therapies
Neurodevelopmental or neuropsychiatric disorder
Failed ITC (ages 6 months - 24 months)
Failed the EI screener (\>24 months)
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

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04639830) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Healthy Children Treatment Options in New York, NY

If you're searching for healthy children treatment options in New York, NY, this clinical trial (NCT04639830) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced healthy children specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all healthy children clinical trials near you to find additional studies recruiting in your area.

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