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Breath Collection from Children for Disease Biomarker Discovery
Published on: February 14, 2019
Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial
Gillian M Nixon1,2, Deborah Anderson3, Alice Baker3,4,5
1Melbourne Children's Sleep Centre, Monash Children's Hospital, Monash Health, Melbourne, Victoria, Australia.
Insights
Intranasal saline effectively resolved obstructive sleep-disordered breathing symptoms in children. Adding intranasal steroids did not improve outcomes, suggesting saline is a suitable first-line treatment before surgery.
Area of Science:
- Pediatric Pulmonology
- Sleep Medicine
- Clinical Trials
Background:
- Obstructive sleep apnea (OSA) is common in children, often requiring adenotonsillectomy.
- Medical treatments offer potential to manage symptoms and reduce surgical necessity.
Purpose of the Study:
- To evaluate the efficacy of intranasal steroids (INS) versus saline in children with persistent obstructive sleep-disordered breathing (OSDB) symptoms.
- To compare symptom resolution rates after a 6-week saline run-in followed by 6 weeks of INS or continued saline.
Main Methods:
- A double-blind, placebo-controlled, randomized clinical trial was conducted in Australia.
- Children aged 3-12 years with persistent OSDB symptoms after a 6-week saline run-in were randomized to INS or saline for an additional 6 weeks.
- Primary outcome was symptom resolution, with secondary outcomes including behavior and quality of life.
Main Results:
- Of 139 children completing the run-in, 29.5% achieved symptom resolution with saline alone.
- Among 93 randomized children, symptom resolution rates were similar between INS (35.6%) and saline (36.4%) groups.
- No significant difference in symptom resolution or secondary outcomes was observed between INS and saline groups.
Conclusions:
- Six weeks of intranasal saline alone resolved OSDB symptoms in nearly one-third of children.
- An additional 6 weeks of INS or saline provided no added benefit, with overall resolution around 50%.
- Intranasal saline is an effective short-term first-line treatment for pediatric OSDB, warranting a 3-month trial before considering further interventions.
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 <-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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