Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005560
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2000-05-25
Brief Title:
Prevalence and Correlates of Childhood Sleep Apnea
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:
2008-01
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 determine if there are anatomic and physical characteristics that distinguish pre-adolescent children with sleep disordered breathing and if the sleep disordered breathing is associated with adverse effects on school and neurocognitive performance
Detailed Description:
BACKGROUND
The study is part of an initiative Obstructive Sleep Apnea in Children which was released 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 The goal of the initiative is to define abnormalities in airway structure and function responsible for obstructive sleep apnea in children ages 3 to 12 and to identify physiological and clinical measures associated with increased morbidity
DESIGN NARRATIVE
A 3 stage stratified sampling procedure is conducted on pre-adolescent Tucson school children between the ages of 6 and 12 years of age Stratification is performed on the following factorsage ethnicity gender and snoring status In the initial phase 2500 625 each year pre-adolescent Tucson school children between the ages of 6 and 12 years of age are surveyed using a questionnaire designed to elicit symptoms of sleep disordered breathing SDB including obstructive sleep apnea OSA From these data a subset of 90 snoring and 30 non-snoring children 500 total will be recruited each year to have home polysomnography basic anthropometric measurements and a battery of neurocognitive tests performed in order to identify a group of children with SDB including OSA and a group without this condition In the third phase of the study 20 children with SDB and 20 without will be recruited each year 80 total to undergo more intensive anatomic and physiologic testing including cephalometry measurement of upper airway geometry and resistance using acoustic reflection and oscillation techniques and control of ventilation studies
The intent of the study is to 1 determine the prevalence of symptoms of SDB in pre-adolescent Caucasian and Hispanic children 2 compare the prevalence of objectively measured SDB in pre-adolescent Caucasian and Hispanic children 3 determine whether there are physiologic and anatomic differences among pre-adolescent children who have SDB including obstructive sleep apnea and upper airway resistance syndrome UARS and those who do not during quiet wakefulness and 4 determine the association between SDB and school performance neuro-cognitive ability and daytime symptoms
The study has been extended through November 2008 to to follow a large cohort of pre-adolescent children to determine whether untreated sleep apnea is associated with identifiable decrements in neurocognitive performance and school performance as well as perturbations of blood pressure and growth at approximately four years after initial enrollment and identification of sleep apnea The study also aims to identify pre-adolescent anthropometric and ethnic variables associated with future development andor regression of sleep apnea The study secondarily aims to determine whether abnormalities in ventilatory drive found in pre-adolescence in children with sleep apnea persist after approximately four years of untreated sleep apnea
The study is part of an initiative Obstructive Sleep Apnea in Children which was released 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 The goal of the initiative is to define abnormalities in airway structure and function responsible for obstructive sleep apnea in children ages 3 to 12 and to identify physiological and clinical measures associated with increased morbidity
DESIGN NARRATIVE
A 3 stage stratified sampling procedure is conducted on pre-adolescent Tucson school children between the ages of 6 and 12 years of age Stratification is performed on the following factorsage ethnicity gender and snoring status In the initial phase 2500 625 each year pre-adolescent Tucson school children between the ages of 6 and 12 years of age are surveyed using a questionnaire designed to elicit symptoms of sleep disordered breathing SDB including obstructive sleep apnea OSA From these data a subset of 90 snoring and 30 non-snoring children 500 total will be recruited each year to have home polysomnography basic anthropometric measurements and a battery of neurocognitive tests performed in order to identify a group of children with SDB including OSA and a group without this condition In the third phase of the study 20 children with SDB and 20 without will be recruited each year 80 total to undergo more intensive anatomic and physiologic testing including cephalometry measurement of upper airway geometry and resistance using acoustic reflection and oscillation techniques and control of ventilation studies
The intent of the study is to 1 determine the prevalence of symptoms of SDB in pre-adolescent Caucasian and Hispanic children 2 compare the prevalence of objectively measured SDB in pre-adolescent Caucasian and Hispanic children 3 determine whether there are physiologic and anatomic differences among pre-adolescent children who have SDB including obstructive sleep apnea and upper airway resistance syndrome UARS and those who do not during quiet wakefulness and 4 determine the association between SDB and school performance neuro-cognitive ability and daytime symptoms
The study has been extended through November 2008 to to follow a large cohort of pre-adolescent children to determine whether untreated sleep apnea is associated with identifiable decrements in neurocognitive performance and school performance as well as perturbations of blood pressure and growth at approximately four years after initial enrollment and identification of sleep apnea The study also aims to identify pre-adolescent anthropometric and ethnic variables associated with future development andor regression of sleep apnea The study secondarily aims to determine whether abnormalities in ventilatory drive found in pre-adolescence in children with sleep apnea persist after approximately four years of untreated sleep apnea
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 |
|---|---|---|---|
| R01HL062373 | NIH | None | httpsreporternihgovquickSearchR01HL062373 |