A randomized trial of adenotonsillectomy for childhood sleep apnea

Abstract

Background: Adenotonsillectomy is commonly performed in children with the obstructive sleep apnea syndrome, yet its usefulness in reducing symptoms and improving cognition, behavior, quality of life, and polysomnographic findings has not been rigorously evaluated. We hypothesized that, in children with the obstructive sleep apnea syndrome without prolonged oxyhemoglobin desaturation, early adenotonsillectomy, as compared with watchful waiting with supportive care, would result in improved outcomes.

Methods: We randomly assigned 464 children, 5 to 9 years of age, with the obstructive sleep apnea syndrome to early adenotonsillectomy or a strategy of watchful waiting. Polysomnographic, cognitive, behavioral, and health outcomes were assessed at baseline and at 7 months.

Results: The average baseline value for the primary outcome, the attention and executive-function score on the Developmental Neuropsychological Assessment (with scores ranging from 50 to 150 and higher scores indicating better functioning), was close to the population mean of 100, and the change from baseline to follow-up did not differ significantly according to study group (mean [±SD] improvement, 7.1±13.9 in the early-adenotonsillectomy group and 5.1±13.4 in the watchful-waiting group; P=0.16). In contrast, there were significantly greater improvements in behavioral, quality-of-life, and polysomnographic findings and significantly greater reduction in symptoms in the early-adenotonsillectomy group than in the watchful-waiting group. Normalization of polysomnographic findings was observed in a larger proportion of children in the early-adenotonsillectomy group than in the watchful-waiting group (79% vs. 46%).

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. (Funded by the National Institutes of Health; CHAT ClinicalTrials.gov number, NCT00560859.).

Figure 1. Study Enrollment and Randomization

A total of 464 children underwent randomization, with 226 children assigned to early adenotonsillectomy and 227 to a strategy of watchful waiting with supportive care. A total of 194 children in the early-adenotonsillectomy group and 203 in the watchful-waiting group were included in the analysis of the primary outcome, the attention and executive-function score on the Developmental Neuropsychological Assessment (NEPSY).

Figure 2. Normalization of Polysomnographic Findings

The percentage of participants with normalization of polysomnographic findings (defined as an apnea–hypopnea index [AHI] score of <2 events per hour or an obstructive apnea index score of <1 event per hour) is shown for black children versus children of other races (Panel A), obese children versus nonobese children (Panel B), and children with baseline AHI scores above the median baseline level of 4.7 events per hour versus those with baseline AHI scores at or below the median baseline level (Panel C). Among children randomly assigned to early adenotonsillectomy, the incidence of normalized polysomnographic findings was significantly higher among children who were not black (P<0.001), children who were not obese (P<0.001), and children who had a baseline AHI score at or below the median value (P<0.05). Similarly, among children randomly assigned to watchful waiting, the incidence of normalized polysomnographic findings was significantly higher among nonblack children (P<0.05), nonobese children (P<0.001), and children with a baseline AHI score at or below the median value (P<0.001).