Impact of Palatal Expansion With Up‐Locker on Children With Sleep‐Disordered‐Breathing: A Clinical Trial

OBJECTIVE: To compare the effect of the palatal expansion with Hyrax and Hyrax + Up-Locker on sleep behavior, snoring and sleep architecture in children with Sleep Disordered Breathing (SDB). MATERIALS AND METHODS: This prospective, single-blind, randomized controlled clinical trial enrolled 34 children aged 6-8 years. Participants were randomly assigned using a computer-generated randomization process to receive treatment with either the Hyrax expansion appliance alone or in combination with the Up-Locker vacuum activator. Sleep architecture was evaluated via polysomnography and sleep behavior through the Children's Sleep Habits Questionnaire (CSHQ). Data were analyzed with Shapiro-Wilks for homogeneity and comparisons were performed with either t-test or Mann-Whitney. RESULTS: Children in the Hyrax + Up-Locker exhibited superior outcomes than in the Hyrax group, including statistically significant reduction in sleep onset delay (p = 0.04) and night wakings (p = 0.02), as well as a notable decrease in snoring (p < 0.001). Children in the Hyrax + Up-Locker vacuum activator group experienced more significant improvements in sleep latency, total sleep time, REM sleep, AHI in REM and nREM sleep, and arousal indices compared to the Hyrax group (p < 0.05) after treatment. CONCLUSION: Combined treatment with Hyrax + Up-Locker vacuum activator yielded superior outcomes in sleep architecture and sleep behavior. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06986343.