Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005516 |
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.
Condition |
---|
Lung Diseases Sleep Apnea Syndromes |
Study Type: | Observational |
Study Design: | Natural History, Defined Population |
Study Start Date: | July 1998 |
Estimated Study Completion Date: | June 2002 |
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 (e.g., snoring, sleepy) from asymptomatic children.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 5035 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005516 History of Changes |
Health Authority: | United States: Federal Government |
Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Lung Diseases |
Respiration Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Apnea Syndromes Pathologic Processes Disease Respiratory Tract Diseases Apnea Syndrome |
Lung Diseases Nervous System Diseases Respiration Disorders Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |