A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome

Abstract

Intranasal corticosteroids (INCS) are frequently used to treat OSA syndrome (OSAS) in children. However, their efficacy has not been rigorously tested. Do INCS result in improved OSAS symptoms, polysomnography findings, behavior, and quality of life compared with placebo? In this randomized, double-blind, placebo-controlled trial, children with OSAS aged 5 to 12 years (N= 134) were randomized 2:1 to receive 3months of INCS or placebo. Children in the INCS arm were then re-randomized to receive 9months of INCS or placebo. Polysomnography, symptoms, and neurobehavioral findings were measured at baseline, 3months, and 12months. The primary outcome was change in obstructive apnea hypopnea index (OAHI) at 3months, available for 122 children. The secondary outcome was OAHI change at 12months, available for 70 children. Median (interquartile range) age and OAHI at baseline for the entire group were 7.9 (6.3 to 9.9) years and 5.8 (3.6 to 9.7) events per hour. OAHI changes at 3months (-1.72 [-3.91 to 1.92] events per hour) and 12months (-1.2 [-4.22 to 1.71] events per hour) were not different between the two groups (P= not significant). OSAS symptoms and neurobehavioral results did not differ between the INCS and placebo groups at 3 and 12months. The 38 children who received INCS for 12months reported a significant OAHI decrease from 7.2 (3.62 to 9.88) events per hour to 3.7 (1.56 to 6.4) events per hour (P= .039). In children with OSAS, treatment with INCS did not result in significant polysomnography, neurobehavioral, or symptom changes at 3 and 12months of treatment. Twelve months of INCS treatment resulted in a statistically significant but not clinically relevant OAHI reduction. ClinicalTrials.gov; No.: NCT02180672; URL: www. gov.