Lung Diseases Clinical Trial
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.
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 factors:age, 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 and/or 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.
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