Mandibular advancement appliances for sleep-disordered breathing in children: A randomized crossover clinical trial

Objective: To test the short-term effectiveness of a mandibular advancement splint (MAS) for the management of sleep-disordered breathing (SDB) in children. Methods: Eighteen SDB children were enrolled in a crossover randomized clinical trial and assigned to a treatment sequence starting either with an Active or a Sham MAS. Each appliance was worn for three weeks and treatment periods were separated by a two-week washout. Home-based polysomnographic data were collected before and after each treatment period. In addition, blood samples were collected at the end of each treatment period to assess serum levels of insulin-like growth factor-1 (IGF-1). The apnea-hypopnea index (AHI) and snoring time represented the main outcome variables. Secondary outcomes included IGF-1 levels, and questionnaire scores for quality of life and behavior. Results: Compared to the Sham MAS, the wearing of the Active MAS resulted in a significant reduction in overall AHI (-37%; 95% CI = 15-53%; p = 0.002) and supine AHI (-4.1 events per hour; 95% CI = 1.8-6.4; p < 0.001). Mean snoring time per night was shorter with the Active MAS than with the Sham MAS (-46.3 min; 95% CI = 14.5-78.1; p=0.004). Wearing of the Active MAS improved the ratings of quality of life and behavior (P <= 0.028), but there was no evidence that it influenced IGF-1 levels (P = 0.172). Conclusion: Wearing an Active MAS overnight, over a short period can be beneficial for SDB children, resulting in a clinically relevant reduction of supine AHI.