Neurobehavioral Consequences of Sleep Apnea in Children

Completed

• Conditions: Lung Diseases; Sleep Apnea Syndromes

• Registration Number: NCT00006323
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2000-10-02
• Study First Submitted QC: 2000-10-02
• Study First Posted: 2000-10-03
• Study Completion: 2004-07
• Status Verified: 2005-03
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified