Efficacy of a Pre-Fabricated Myofunctional Appliance for the Treatment of Mild to Moderate Pediatric Obstructive Sleep Apnea: A Preliminary Report.

OBJECTIVE: The purpose of this study was to determine the efficacy of the Myobrace/MyOSA myofunctional appliance for the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in children, by means of the Apnea/Hypopnea Index (AHI).

STUDY DESIGN: Nine children with a diagnosis of mild to moderate OSA were included in the study. The subjects wore the Myobrace/MyOSA myofunctional appliance for a period of 90 days. The initial AHI, determined by means of a sleep test, was used as baseline (To), and a second AHI, computed at the end of the experimental period, was used as final data (T1 ). The differences between the AHIs at To and T1 were calculated (diff AHI) and used for statistical purposes. The level of Oxygen Saturation (SaO2 ) was also recorded before and after treatment, and their differences calculated as diff SaO2 . Statistical analysis was performed with a paired-t- test and statistical significance was established at 95 per cent level of confidence.

RESULTS: A statistical significant reduction in the AHI of the studied subjects was computed at the end of the experimental period (p = 0.0425). Although there was an improvement in the SaO2 , it did not reach a statistically significant difference.

CONCLUSIONS: The present results suggest that the Myobrace/MyOSA myofunctional appliance can be an alternative to treat mild to moderate OSA in children. However further studies are necessary to determine the stability of the results after treatment.