Multicenter clinical trial for the treatment of obstructive sleep apnea with a non-permanent orthodontic intraoral device in children

PMCID: PMC12174215

PMID: 40526156

DOI: 10.1007/s00431-025-06254-x

Journal: European journal of pediatrics

Publication Date: 2025-6-17

Authors: Kushida CA, Stevens J, Bennett M, Heit T, Klemp D, et al.

Key Points

• First FDA-cleared non-permanent orthodontic device specifically designed for pediatric OSA treatment
• 61.7% of participants achieved >50% AHI reduction, with 17% completely resolving OSA
• Offers a potentially less invasive alternative to traditional OSA interventions with no reported adverse effects

Summary

This groundbreaking study evaluated a novel non-permanent orthodontic oral appliance for treating pediatric obstructive sleep apnea (OSA), addressing critical limitations of existing interventions like adenotonsillectomy and positive airway pressure. The non-randomized interventional pre-post study involved 47 children, demonstrating significant improvements across multiple clinical endpoints through a slow maxillary expansion device worn intermittently during evenings and sleep.

The device showed remarkable efficacy, with 79% of participants experiencing OSA severity improvement, including 61.7% achieving over 50% reduction in apnea-hypopnea index (AHI). Notably, 93% of children with severe OSA showed substantial improvement, with 17% completely resolving their condition. Objective measurements revealed a 67.8% increase in airway volume, 31% reduction in sleep disorder symptoms, and a consistent 13% increase in intermolar width, suggesting a comprehensive therapeutic approach with minimal invasiveness.