O010 Nasal sprays for children with sleep-disordered breathing: the MIST+ trial

Abstract Introduction The MIST+ trial was a randomized, double-blind, placebo-controlled trial evaluating the efficacy of 6 weeks of intranasal steroid (INS) compared to saline in children with obstructive sleep-disordered breathing (oSDB) with persistent symptoms after a 6-week intranasal saline run-in. Methods Children 3-12y were recruited from specialist clinic waitlists at two sites. All received once daily intranasal saline for 6 weeks (run-in). Those with persisting symptoms (Brouillette score ≥ -1) were randomized to either once daily intranasal mometasone furoate 50ug (INS) or continued saline for a further 6 weeks. The primary outcome was symptom resolution (score < -1). Secondary outcomes included behaviour, quality of life and parental perception of need for surgery. Analyses were adjusted for site and baseline measures. Results Of 150 children (38%F; age 6.2 ± 2.3years), 29.5% had symptom resolution after saline run-in. Symptom resolution was less likely in those with baseline symptom scores above the median (OR 0.22, 95%CI 0.1,0.49, p<.001). Among 93 randomised (47 INS; 46 saline), symptom resolution occurred in 35.6% (INS, 95%CI 22.9,50.6%) and 36.4% (saline, 95%CI 23.5,51.6%), with no evidence for a clinically significant difference between groups (-0.86, 95%CI -20.7,19.0, p=.93). No group differences were found in secondary outcomes. Conclusion Six weeks of intranasal saline resolves oSDB symptoms in nearly one-third of children. An additional 6-week course of INS or saline leads to resolution in another third (total resolution around 50%), with no added benefit from INS. Intranasal saline is an effective short-term first-line treatment for oSDB prior to consideration of polysomnography or surgical intervention.