Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006323
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-10-02
Brief Title:
Neurobehavioral Consequences of Sleep Apnea in Children
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
To identify physiological and clinical measures of obstructive sleep-disordered breathing that are associated with increased morbidity in children
Detailed Description:
BACKGROUND
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
This cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in Massachusetts enrolled in the on-going Infant Care Practices Study Stratified sampling was used to assemble a cohort of 250 children with habitual snoring 3 nightsweek 100 children with occasional snoring 3 nightsweek and 100 non-snoring children These children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation in order to test the hypothesis that after adjusting for potential confounding variables both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains immediate attention sustained attention working memory and symptoms of hyperactivity These data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old children
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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
This cross-sectional study recruited a population-based sample of young children from among the more than 8000 children in Massachusetts enrolled in the on-going Infant Care Practices Study Stratified sampling was used to assemble a cohort of 250 children with habitual snoring 3 nightsweek 100 children with occasional snoring 3 nightsweek and 100 non-snoring children These children were studied within 3 months of their fourth birthday using overnight laboratory polysomnography and a detailed neurobehavioral evaluation in order to test the hypothesis that after adjusting for potential confounding variables both parent-reported snoring and polysomnographic measures were associated with standardized measures of the following neurobehavioral domains immediate attention sustained attention working memory and symptoms of hyperactivity These data also provided an opportunity to determine normal values for polysomnographic measures in 4-year-old children and to determine the prevalence of snoring and polysomnographic abnormalities among 4-year-old children
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062371 | NIH | None | httpsreporternihgovquickSearchR01HL062371 |