Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04639830
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2020-11-20
Brief Title:
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Status:
RECRUITING
Status Verified Date:
2024-08-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
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 andor 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
Detailed Description:
This is a multisite longitudinal study with NIH as the lead site The other sites Texas Children s Hospital Boston Children s Hospital Geisinger Medical Center NYU and the NHLBI- supported area specific repository National Sleep Research Repository NSRR This study will address the data gap established by two NIMH sponsored intramuralextramural workshops 2017 and 2018 in the field of sleep and neurodevelopment by establishing a standardized reliable protocol for real time acquisition of research data on the normal and abnormal neuro-maturational changes that are sleep-dependent It will facilitate data-sharing in this area and speed the pace of discovery Sleep EEG is a highly advantageous modality to provide non-invasive reliable robust and reproducible imaging of the brain in young and neurodevelopmentally disordered populations Sleep EEG affords data acquisition of functional network microstructure with a decreased signal to noise ratio compared to acquisition in the awake state In addition potential deviations from the natural ultradian and other sleep oscillatory patterns of the sleep process have the potential to inform on underlying developing neuropathology of various microstructures and neurotransmitter systems prior to the emergence of putatively associated behavioral phenomenon Ideally these oscillatory trajectories will not only map to developmental behavioral phenotypes but also to clinical disorders of the sleep state itself such as the malignant insomnias that are prevalent in neuropsychiatric and neurodevelopmental syndromes The protocol will initiate the establishment of a normative database for electrophysiologic sleep data in the developing brain Disorders of particular interest include autism disorders of social cognition and other neurodevelopmental disorders childhood psychiatric disorders and unique clinical presentations of neurogenetic syndromes such as those associated with genetic disorders or those with a unique family history The study plans to use a quantitative dimensional approach to outcome measurement with respect to adaptive functioning in children and to symptoms of behavioral andor neurodevelopmental problems irrespective of diagnosis
While specific differences in the architecture of sleep eg stages movement abnormalities cyclicity spindles and other bio-signatures that reflect anatomical microstructure may be used to differentiate neurodevelopmental cohorts the enormous potential of this proposed database lies in the ability to track functional connectivity coherence during sleep in the developing brain in a longitudinal prospective manner thereby establishing both normal and aberrant trajectories Predictive relationships can be determined once these trajectories are established Coherence studies would allow for the potential recreation of neural circuits that sub-serve various brain functions such as language and attention Tracking the trajectory of neural development prior to and during the developmental window when these circuits are maturing will allow for an understanding of best potential windows of intervention
Objectives The long term primary objective of this protocol is to evaluate the degree to which the development and maturation of sleep patterns with an emphasis on the relationship of those patterns to electrophysiologic signals can predict cognitive and behavioral outcomes Assessing participants over time will allow researchers to gain additional knowledge about the role of abnormal sleep measured both clinically and by polysomnogram in various childhood neuropsychiatric neurodevelopmental disorders and behavioral syndromes
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 neurodevelopmentalneuropsychiatric disorders based on any one or more of the following criteria
1 Enrolled in early intervention
2 Getting any targeted therapies
3 Neurodevelopmental or neuropsychiatric disorder
4 Failed Infant Toddler Checklist ITC ages 6 months 24 months
5 Failed the Early Intervention EI screener 24 months
Design Study 1 N 90 and Study 2 N 154 use the same accelerated longitudinal design
Outcome Measures The primary outcome measure in Study 1 is sleep spindle activity Study 2 has an additional primary outcome the Vineland Adaptive Behavior VABS Socialization growth scale In both studies secondary outcome measures will includeother characteristics of sleep spindles sleep rhythms ultradian circadian macroarchitecture stages and latencies microarchitecture measures of connectivity and network analyses
Predictors include other neurodevelopmental variables including other domain scores from the Vineland IQ and quantitative measurement of behavioral problems and social communicative development
While specific differences in the architecture of sleep eg stages movement abnormalities cyclicity spindles and other bio-signatures that reflect anatomical microstructure may be used to differentiate neurodevelopmental cohorts the enormous potential of this proposed database lies in the ability to track functional connectivity coherence during sleep in the developing brain in a longitudinal prospective manner thereby establishing both normal and aberrant trajectories Predictive relationships can be determined once these trajectories are established Coherence studies would allow for the potential recreation of neural circuits that sub-serve various brain functions such as language and attention Tracking the trajectory of neural development prior to and during the developmental window when these circuits are maturing will allow for an understanding of best potential windows of intervention
Objectives The long term primary objective of this protocol is to evaluate the degree to which the development and maturation of sleep patterns with an emphasis on the relationship of those patterns to electrophysiologic signals can predict cognitive and behavioral outcomes Assessing participants over time will allow researchers to gain additional knowledge about the role of abnormal sleep measured both clinically and by polysomnogram in various childhood neuropsychiatric neurodevelopmental disorders and behavioral syndromes
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 neurodevelopmentalneuropsychiatric disorders based on any one or more of the following criteria
1 Enrolled in early intervention
2 Getting any targeted therapies
3 Neurodevelopmental or neuropsychiatric disorder
4 Failed Infant Toddler Checklist ITC ages 6 months 24 months
5 Failed the Early Intervention EI screener 24 months
Design Study 1 N 90 and Study 2 N 154 use the same accelerated longitudinal design
Outcome Measures The primary outcome measure in Study 1 is sleep spindle activity Study 2 has an additional primary outcome the Vineland Adaptive Behavior VABS Socialization growth scale In both studies secondary outcome measures will includeother characteristics of sleep spindles sleep rhythms ultradian circadian macroarchitecture stages and latencies microarchitecture measures of connectivity and network analyses
Predictors include other neurodevelopmental variables including other domain scores from the Vineland IQ and quantitative measurement of behavioral problems and social communicative development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-M-0166 | None | None | None |