Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006321
Status:
TERMINATED
Last Update Posted:
2017-04-10
First Post:
2000-10-02
Brief Title:
Neurocognitive Function in Snoring Children
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left the university
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess associations between behavioralneuropsychological measures and various measures of sleep disordered breathing SDB and to determine the prevalence of SDB in children with Attention Deficit Hyperactivity Disorder ADHD
Detailed Description:
BACKGROUND
Obstructive sleep apnea syndrome OSAS is a relatively frequent condition which may affect up to 2-3 percent of school age children The morbidity of untreated OSAS may include failure to thrive pulmonary and systemic hypertension and behavioral and neurocognitive deficiencies However it remains unclear to what extent OSAS impinges on aspects of neurocognitive and behavioral function and whether sleep fragmentation intermittent hypoxemia and alveolar hypoventilation which are the three major physiological alterations in OSAS selectively affect particularly vulnerable components of neurocognitive function Furthermore certain similarities exist between the behavioral alterations occurring in OSAS and those seen in children with the Attention Deficit Hyperactivity Disorder ADHD
The study is in response to a Request for Applications RFA on Obstructive Sleep Apnea in Children NHLBI issued the RFA in December 1997 with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development
DESIGN NARRATIVE
The cross-sectional study tested the hypothesis that OSAS is detrimental to particular aspects of neurocognitive and behavioral functioning Snoring 6 year-old children attending the public elementary school system in New Orleans Parish were prospectively identified by an appropriate questionnaire and enrolled in the study Snoring children underwent overnight polysomnographic assessment to determine the presence and severity of OSAS and their neurocognitive and behavioral functions were subsequently evaluated employing the Wechsler Intelligence Scale for Children-III the Conners Continuous Performance Test and the Cambridge Neuropsychological Test Automated Battery test Multivariate regression and analyses of variance allowed for determination of aspects of neurocognitive function and behavior that were vulnerable to OSAS in general and to each of OSAS components in particular
The study also tested the hypothesis that children with ADHD may have increased prevalence of snoring and OSAS Children with this diagnosis were initially confirmed as having ADHD using the revised Diagnostic Interview for Children and Adolescents the Conners Parent Rating Scale and the Child Behavior Checklist ADHD children then underwent polysomnographic evaluation as well as extensive evaluation of neurocognitive function and behavior as above The prevalence of snoring and OSAS were then calculated
The study was extended through June 2007 to test the hypothesis that SDB will induce systemic inflammatory responses and that the magnitude of such inflammatory response will be the major determinant of the severity of neurocognitive dysfunction associated with SDB
Obstructive sleep apnea syndrome OSAS is a relatively frequent condition which may affect up to 2-3 percent of school age children The morbidity of untreated OSAS may include failure to thrive pulmonary and systemic hypertension and behavioral and neurocognitive deficiencies However it remains unclear to what extent OSAS impinges on aspects of neurocognitive and behavioral function and whether sleep fragmentation intermittent hypoxemia and alveolar hypoventilation which are the three major physiological alterations in OSAS selectively affect particularly vulnerable components of neurocognitive function Furthermore certain similarities exist between the behavioral alterations occurring in OSAS and those seen in children with the Attention Deficit Hyperactivity Disorder ADHD
The study is in response to a Request for Applications RFA on Obstructive Sleep Apnea in Children NHLBI issued the RFA in December 1997 with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development
DESIGN NARRATIVE
The cross-sectional study tested the hypothesis that OSAS is detrimental to particular aspects of neurocognitive and behavioral functioning Snoring 6 year-old children attending the public elementary school system in New Orleans Parish were prospectively identified by an appropriate questionnaire and enrolled in the study Snoring children underwent overnight polysomnographic assessment to determine the presence and severity of OSAS and their neurocognitive and behavioral functions were subsequently evaluated employing the Wechsler Intelligence Scale for Children-III the Conners Continuous Performance Test and the Cambridge Neuropsychological Test Automated Battery test Multivariate regression and analyses of variance allowed for determination of aspects of neurocognitive function and behavior that were vulnerable to OSAS in general and to each of OSAS components in particular
The study also tested the hypothesis that children with ADHD may have increased prevalence of snoring and OSAS Children with this diagnosis were initially confirmed as having ADHD using the revised Diagnostic Interview for Children and Adolescents the Conners Parent Rating Scale and the Child Behavior Checklist ADHD children then underwent polysomnographic evaluation as well as extensive evaluation of neurocognitive function and behavior as above The prevalence of snoring and OSAS were then calculated
The study was extended through June 2007 to test the hypothesis that SDB will induce systemic inflammatory responses and that the magnitude of such inflammatory response will be the major determinant of the severity of neurocognitive dysfunction associated with SDB
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 |
|---|---|---|---|
| R01HL065270 | NIH | None | httpsreporternihgovquickSearchR01HL065270 |