Trials / Completed
CompletedNCT00006323
Neurobehavioral Consequences of Sleep Apnea in Children
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- —
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI) · NIH
- Sex
- All
- Age
- 100 Years
- Healthy volunteers
- Not accepted
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 nights/week), 100 children with occasional snoring (\<3 nights/week), 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.
Conditions
Timeline
- Start date
- 1999-09-01
- Completion
- 2004-07-01
- First posted
- 2000-10-03
- Last updated
- 2016-05-13
Source: ClinicalTrials.gov record NCT00006323. Inclusion in this directory is not an endorsement.