A Randomized Controlled Study of Adenotonsillectomy for Children with Obstructive Sleep Apnea Syndrome (CHAT)
Note that you will be prompted to log in or register an account
                                        Accession Number
                                        HLB01191414a
                                    
                                    Study Type
                                    Clinical Trial
                                
                                    Collection Type
                                    Open BioLINCC Study
                                    
                                        See bottom of this webpage for request information
                                    
                                
                                        Study Period
                                        October 2007 – June 2012
                                    
                                        NHLBI Division
                                        DLD
                                    
                                        Dataset(s) Last Updated
                                        January 3, 2018
                                    
                                    Clinical Trial URLs
                                    
                                        
    
        NCT00560859
    
    
                                    
                                
                                    Primary Publication URLs
                                    
                                        
    
        23692173
    
    
                                    
                                
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Objectives
The Childhood Adenotonsillectomy Trial (CHAT) was designed to evaluate the efficacy of early adenotonsillectomy versus watchful waiting with supportive care, with respect to cognitive, behavioral, quality-of-life, and sleep factors at 7 months of follow-up, in children with the obstructive sleep apnea syndrome.
Background
Childhood obstructive sleep apnea syndrome is associated with numerous adverse health outcomes, including cognitive and behavioral deficits. The most commonly identified risk factor for the childhood obstructive sleep apnea syndrome is adenotonsillar hypertrophy. Thus, the primary treatment is adenotonsillectomy, which accounts for more than 500,000 procedures annually in the United States alone. However its usefulness in reducing symptoms and improving cognition, behavior, quality of life, and polysomnographic findings has not been rigorously evaluated.
Participants
A total of 464 children underwent randomization. Eligible children were 5 to 9 years of age, had the obstructive sleep apnea syndrome without prolonged oxyhemoglobin desaturation, and were considered to be suitable candidates for adenotonsillectomy. The obstructive sleep apnea syndrome was defined as an obstructive apnea–hypopnea index (AHI) score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour. Children with an AHI score of more than 30 events per hour, an OAI score of more than 20 events per hour, or arterial oxyhemoglobin saturation of less than 90% for 2% or more of the total sleep time were not eligible.
Design
CHAT was a multicenter, single-blind, randomized, controlled trial at seven academic sleep centers. Children were randomly assigned to early adenotonsillectomy (surgery within 4 weeks after randomization) or a strategy of watchful waiting. At the baseline visit, children with coexisting conditions that could exacerbate the obstructive sleep apnea syndrome (e.g., allergies and poorly controlled asthma) were referred for treatment as needed. Children underwent standardized polysomnographic testing with scoring at a centralized sleep reading center, cognitive and behavioral testing, and other clinical and laboratory evaluations at baseline and 7 months after randomization. At both examinations, caregivers were asked to complete survey instruments, and teachers were mailed behavioral assessments. The primary study outcome was the change in the attention and executive-function score on the Developmental Neuropsychological Assessment.
Conclusions
As compared with a strategy of watchful waiting, surgical treatment for the obstructive sleep apnea syndrome in school-age children did not significantly improve attention or executive function as measured by neuropsychological testing but did reduce symptoms and improve secondary outcomes of behavior, quality of life, and polysomnographic findings, thus providing evidence of beneficial effects of early adenotonsillectomy.
N Engl J Med. 2013 Jun 20;368(25):2366-76.
Please note that researchers must be registered on this site to submit a request, and you will be prompted to log in. If you are not registered on this site, you can do so via the Request button. Registration is quick, easy and free.
Resources Available
Study Datasets OnlyStudy Documents
Persons using assistive technology may not be able to fully access information in the study documents. For assistance, Contact BioLINCC and include the web address and/or publication title in your message. If you need help accessing information in different file formats such as PDF, XLS, DOC, see Instructions for Downloading Viewers and Players.