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Impact of Treatment of Mild Sleep-Disordered Breathing on Children’s Health-CCC

The Problem

Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children in the US. There are more than 500,000 operations annually and many of these are performed in children with primary snoring, or mild sleep-disordered breathing (MSDB) rather than in children with frank obstructive sleep apnea. AT improves behavior and quality of life in school-aged children with sleep apnea, but its benefit to children with MSDB is not known, resulting in large practice and geographic variations in its use. Considering the morbidity and health care costs of AT, it is crucial to determine the impact of the surgery on outcomes that are of value to patients and to the healthcare system.

Hypothesis

The overall hypothesis of this study is that children with MSDB benefit from AT as defined by improved behavior and attention (primary outcomes) and decreased health care utilization.

Method

We propose to take advantage of current successful collaboration of leaders in sleep medicine, otolaryngology, neuropsychology and clinical trials to conduct a randomized clinical trial of AT for MSDB.

Using a single-blinded, randomized design, we aim to recruit 460 children (50% minority), aged 3-9 years, with polysomnographically-confirmed MSDB from 5 leading pediatric centers. Participants will be randomized to early AT or watchful waiting with supportive care, and undergo standardized evaluations of sleep, behavior, attention, quality of life, and health care utilization at baseline and 12 months. Body habitus, urinary cotinine levels, actigraphy, family functioning, atopy and socioeconomic status will be assessed to identify potential moderating influences.

The rigorous design and comprehensive study will resolve existing uncertainties on initial management approaches for pediatric MSDB by addressing several critical issues:

  • Assess outcomes of importance to children and their families, particularly the patient-reported outcomes of behavior, quality of life, and sleep disturbances
  • Examine differences in treatment responses among children who are at increased risk for MSDB, such as pre-school children, minorities, and children with asthma or obesity
  • Evaluate health care utilization as a unique and timely outcome
  • Assess moderating influences of second hand smoke, insufficient sleep, socioeconomic status and family functioning

Results

Study results will provide evidence on whether children with MSDB benefit from surgery and will identify subgroups who are most likely to benefit, thus informing future management approaches of this common pediatric condition and helping to direct resources to those children most likely to benefit.

Public Health Relevance

Adenotonsillectomy is one of the most common surgical procedures performed in children in the US, usually for symptoms of obstructed breathing during sleep and snoring, but often without actual obstructive sleep apnea (i.e., those with mild sleep-disordered breathing [MSDB]). However, the effects of surgery on MSDB is not known. This study will evaluate the effects of adenotonsillectomy on behavior, attention and health care utilization in children with MSDB, as well as identify subgroups of children who are most likely to benefit, thus informing future management approaches of this common pediatric condition and helping to direct resources to those children most likely to benefit.