Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial
In children with ongoing sleep-related breathing symptoms, a daily saltwater nose spray improved symptoms, and adding a steroid nose spray did not help more.
*Randomized, double-blind, placebo-controlled trial; Level 1b (OCEBM).
*Randomized, double-blind, placebo-controlled trial; Level 1b (OCEBM).
Citation
Nixon GM, Anderson D, Baker A, et al. Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial. JAMA Pediatrics. 2026;180(3):240-249. doi:10.1001/jamapediatrics.2025.5717. ClinicalTrials.gov: NCT05382494.
Background
Sleep-related breathing symptoms in children are common and can lead to referrals for sleep testing or surgery, which may be delayed and carry risk. This study tested whether a steroid nose spray provides added benefit after an initial course of saltwater nose spray.
Patients
Children aged 3 to 12 years in Australia referred for obstructive sleep-related breathing symptoms. Important exclusions: prior tonsil/adenoid/nasal surgery; very high body weight; craniofacial, neuromuscular, or genetic conditions affecting sleep; recent nosebleeds; current nasal infection; recent steroid nose spray, steroid pills, or montelukast use; signs suggesting severe disease while awake.
Intervention
After a 6-week saltwater run-in, children with persistent symptoms were randomized to mometasone steroid nose spray once daily for 6 weeks.
Control
Continued saltwater nose spray once daily for 6 weeks.
Outcome
Primary: symptom resolution based on a parent-reported sleep-disordered breathing symptom score (resolution defined as score < −1). Secondary: behavior, quality of life, and parent views about surgery/referral.
Follow-up Period
12 weeks of treatment total (6-week run-in plus 6-week randomized phase), with an additional 6-week survey follow-up.
Results
| Study phase/group | Children with symptom resolution |
|---|---|
| After 6-week saltwater run-in (n=139 with outcome data) | 41/139 (29.5%) |
| Randomized steroid spray for 6 weeks | 16/45 (35.6%) |
| Randomized continued saltwater for 6 weeks | 16/44 (36.4%) |
There was no meaningful difference between steroid and saltwater for symptom resolution or secondary outcomes. Nose irritation and small nosebleeds occurred at similar, low rates during the randomized phase.
Limitations
No “watchful waiting” (no-spray) group, so some improvement might have occurred without treatment. Outcomes were based on parent-reported symptoms rather than overnight sleep testing, and follow-up was relatively short.
Funding
Garnett Passe and Rodney Williams Memorial Foundation; funder had no role.
Clinical Application
For most children with sleep-related breathing symptoms, start daily saltwater nose spray for about 3 months before ordering sleep tests or referring for surgery.
Discussion
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In this double-blind randomized clinical trial, intranasal mometasone did not improve OSDB symptom resolution compared with continued saline after saline run-in (35.6% vs 36.4%; risk difference −0.9%). How should we weigh the trial’s validity and applicability before recommending 12 weeks of saline before specialist referral? In the randomized phase, symptom resolution occurred in 35.6% of children receiving intranasal steroid and 36.4% receiving saline, with a risk difference of −0.9% and 95% CI −20.7% to 19.0% (P=.93). Which interpretation is most appropriate?