Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005516
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Epidemiology of Sleep Disordered Breathing 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 collect fundamental data regarding the distribution of measures of sleep disordered breathing SDB in a pediatric population prevalence of clinically significant SDB in children risk factors and associated co-morbidity
Detailed Description:
BACKGROUND
Developing strategies for recognizing and treating children with Sleep Disordered Breathing SDB was not possible in the absence of essential epidemiological data that addressed the distribution of measures of SDB in pediatric populations The potential public health importance of this was underscored by preliminary data that suggested that risk of SDB was increased in susceptible populations in particular in African Americans and in children born prematurely
DESIGN NARRATIVE
The design was that of a cohort study with a nested case control arm Sleep disordered breathing was evaluated in 850 children with in-home state-of-the art respiratory monitoring techniques A number of risk factors were evaluated sociodemographic characteristics anthropometry upper and lower airway size and function questionnaire spirometry and reflectometry perinatal exposures from neonatal records family history and home environment passive smoking sleep patterns maternal-child stress indices Behavior cognitive skills attention and health-related quality of life were assessed with standardized instruments to assess co-morbidities potential SDB outcomes Analysis of the longitudinal data provided cognitive-developmental trajectories that were evaluated in relationship to SDB The case-control arm confirmed and extended the findings of the in-home assessments with comprehensive laboratory polysomnography cephalometry and objective measures of sleepiness Multiple Sleep Latency Tests in three groups of children definite SDB by home assessment equivocal SDB and no SDB Collection of comprehensive polysomnographic data helped to identify which measures best discriminated symptomatic eg snoring sleepy from asymptomatic 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
Developing strategies for recognizing and treating children with Sleep Disordered Breathing SDB was not possible in the absence of essential epidemiological data that addressed the distribution of measures of SDB in pediatric populations The potential public health importance of this was underscored by preliminary data that suggested that risk of SDB was increased in susceptible populations in particular in African Americans and in children born prematurely
DESIGN NARRATIVE
The design was that of a cohort study with a nested case control arm Sleep disordered breathing was evaluated in 850 children with in-home state-of-the art respiratory monitoring techniques A number of risk factors were evaluated sociodemographic characteristics anthropometry upper and lower airway size and function questionnaire spirometry and reflectometry perinatal exposures from neonatal records family history and home environment passive smoking sleep patterns maternal-child stress indices Behavior cognitive skills attention and health-related quality of life were assessed with standardized instruments to assess co-morbidities potential SDB outcomes Analysis of the longitudinal data provided cognitive-developmental trajectories that were evaluated in relationship to SDB The case-control arm confirmed and extended the findings of the in-home assessments with comprehensive laboratory polysomnography cephalometry and objective measures of sleepiness Multiple Sleep Latency Tests in three groups of children definite SDB by home assessment equivocal SDB and no SDB Collection of comprehensive polysomnographic data helped to identify which measures best discriminated symptomatic eg snoring sleepy from asymptomatic 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 |
|---|---|---|---|
| R01HL060957 | NIH | None | httpsreporternihgovquickSearchR01HL060957 |