What question did this study set out to answer?

To assess the effectiveness of intranasal steroids compared to saline in children with obstructive sleep-disordered breathing who have persistent symptoms.

January 22, 2026

Intranasal Treatments for Children With Sleep-Disordered Breathing

Key Points

To assess the effectiveness of intranasal steroids compared to saline in children with obstructive sleep-disordered breathing who have persistent symptoms.
Double-blind, placebo-controlled, randomized clinical trial
Involved children aged 3 to 12 years from specialist clinics in Australia
Participants received 6 weeks of intranasal saline, followed by 6 weeks of either intranasal mometasone furoate or saline for those with persistent symptoms
Primary outcome measured was symptom resolution based on SDB score
Secondary outcomes included behavioral changes and parental perceptions of surgical necessity.
41 children (29.5%) resolved symptoms after the saline run-in phase
Among those randomized, symptom resolution was 35.6% in the intranasal steroid group and 36.4% in the saline group
No statistically significant differences in primary or secondary outcomes
Both treatments resulted in approximately 50% total symptom resolution after 12 weeks
Saline was established as an effective initial treatment option before considering surgery.

Abstract

Importance Symptoms of obstructive sleep apnea are common in childhood and associated with significant comorbidity. Surgical treatment with adenotonsillectomy is first-line treatment but medical treatments show potential to improve symptoms and reduce the need for surgery. Objective To determine the efficacy of 6 weeks of intranasal steroid (INS) compared with saline in children with obstructive sleep-disordered breathing (OSDB) with persistent symptoms after a 6-week intranasal saline run-in. Design, Setting, and Participants This was a double-blind, placebo-controlled, randomized clinical trial involving specialist clinic waitlists at 2 sites in Australia. Included were children aged 3 to 12 years. Study data were analyzed from January to June 2025. Interventions All children received once-daily intranasal saline for 6 weeks (run-in). Those with persisting symptoms (SDB score ≥−1) were randomized to either once-daily intranasal mometasone furoate, 50 µg, (INS) or continued saline for a further 6 weeks. Main Outcomes and Measures The primary outcome was symptom resolution (SDB score lt;−1). Secondary outcomes included behavior, quality of life, and parental perception of need for surgery. Analyses were adjusted for site and baseline measures. Results A total of 150 children (mean SD age, 6.2 2.3 years; 93 male 62%) were recruited. Of 139 children who completed the run-in phase, 41 (29.5%) had symptom resolution after saline run-in. Among 93 children randomized to intervention groups (47 INS; 46 saline), symptom resolution occurred in 35.6% (95% CI, 22.9%-50.6%) and 36.4% (95% CI, 23.5%-51.6%) of the INS and saline group, respectively, with no evidence for a clinically significant difference between groups (risk difference, −0.9%; 95% CI, −20.7% to 19.0%; P = .93). No group differences were found in secondary outcomes. Subgroup analysis did not reveal a group more or less likely to respond to medical treatment. Conclusions and Relevance Results of this randomized clinical trial show that 6 weeks of intranasal saline resolved OSDB symptoms in nearly one-third of children. An additional 6-week course of INS or saline led to resolution in another one-third (total resolution around 50%), with no added benefit from INS. Intranasal saline is an effective short-term first-line treatment for OSDB before consideration of polysomnography or surgical intervention. Results suggest that saline should be recommended for 3 months before assessing the need for specialist referral. Trial Registration ClinicalTrials.gov Identifier: NCT05382494

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Cite This Study

Nixon et al. (Tue,) studied this question.

synapsesocial.com/papers/6971bdcf642b1836717e272b https://doi.org/https://doi.org/10.1001/jamapediatrics.2025.5717

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