Twelve weeks of intranasal saline performed as well as steroids, which researchers say supports a primary-care-led approach.
A prolonged course of intranasal saline is as effective as intranasal corticosteroids for treating obstructive sleep-disordered breathing in children, according to detailed results from an Australian trial.
The findings from the MIST+ randomised clinical trial reinforced the case for saline as a true first-line therapy rather than a neutral placebo.
An evidence-based, low-risk intervention that could be started early had the potential to reduce symptom burden and unnecessary escalation of care, the researchers wrote.
“Results show that treatment of symptoms of OSDB with 12 weeks of intranasal saline before referral to specialist services is likely to result in a reduced demand for specialist services,” they wrote.
Their findings have been published in JAMA Paediatrics.
The study involved researchers at Monash University and Melbourne Children’s Sleep Centre (part of Monash Children’s Hospital), in collaboration with the Murdoch Children’s Research Institute and the Royal Children’s Hospital.
Adjunct Clinical Professor Gillian Nixon, lead author of the MIST+ study and Paediatric Respiratory and Sleep Specialist at Monash Children’s Hospital and the Department of Paediatrics at Monash University, said these were important findings.
The saline nasal sprays alone could make a real difference for many children to sleep better without the need for steroid sprays or surgery, she explained, which come with a higher chance of potential side effects, costs and longer recovery time.
“It won’t work for everyone, but it does work for a substantial subset of the kids and so we think for all those reasons, for resource reasons and for safety reasons for kids, it’s worth doing first and then seeing,” she told The Medical Republic.
“Some children have very severe, huge tonsils and obviously, nasal sprays are not going to change the size of the tonsils.
“Each child’s different, but it doesn’t hurt to try something low risk first, just because it’s such a common problem that people often put up with for quite a while.”
Professor Nixon said treatment would be best suited for the primary care setting, with GPs well-placed to help guide parents with the use of the spray, rather than parents simply buying it off the shelf and using it at home.
“There are children with very severe symptoms and there are children with other medical problems and other things, so it was always aimed to be a primary care option,” she said.
OSDB is common in childhood and associated with impaired behaviour, cognition, sleep quality and family functioning, yet access to polysomnography and otolaryngology services is frequently delayed.
The study enrolled 150 children aged three to 12 years who had been referred to specialist services for symptoms consistent with obstructive sleep-disordered breathing, including habitual snoring and other features suggestive of obstructive sleep apnoea.
All children received once-daily intranasal saline for six weeks (run-in). Those with persisting symptoms (SDB score ≥−1) were randomised to either once-daily intranasal mometasone furoate (INS) 50 µg or continued saline for a further six weeks.
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Of 139 children who completed the run-in phase, 41 (29.5%) had symptom resolution after saline run-in. Among 93 children randomised 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).
The implications for clinical practice were significant, the researchers said. Obstructive sleep-disordered breathing affects up to 12% of children and remains the leading indication for adenotonsillectomy.
While surgery is effective, it carries cost, perioperative risk and long waiting times in many health systems. Current guidelines often prompt early referral for polysomnography or surgical assessment, pathways that can result in months or years of delay before definitive management.
The MIST+ data suggested a different approach was viable. A structured three-month trial of intranasal saline, initiated in primary care, could resolve symptoms in approximately half of children before they reach specialist services.
Even among initial non-responders, persistence with saline appears just as effective as escalation to intranasal steroids. Importantly, no subgroup was identified in whom steroids conferred added benefit, challenging the long-standing assumption that corticosteroids are the logical next step after saline.
Secondary outcomes, including sleep quality, behaviour, emotional functioning and quality of life, showed no advantage for corticosteroids. Subgroup analyses found no signal that age, tonsillar hypertrophy, allergic rhinitis, overweight, obesity or baseline symptom severity modified treatment response.
Adherence remained high during the randomised phase, particularly in the saline group, and treatment satisfaction was comparable between groups. Although sustained symptom resolution at 12 weeks from the start of the randomised phase appeared numerically lower in the steroid group than in the saline group, overall symptom improvement from baseline was similar, reinforcing the absence of a steroid-specific effect.
Safety findings were reassuring; adverse events were common but largely mild and evenly distributed between groups. Nasal irritation and minor epistaxis occurred at low rates, with all bleeding episodes small in volume and self-limiting. There was no evidence that corticosteroids reduced adverse nasal symptoms compared with saline.
Professor Nixon said there was no doubt that this was an effective treatment for many patients.
“If we end up deciding that surgery is the right treatment – this is more in the context of sleep studies, but it also applies to medical treatment – then we go into that knowing that we’ve tried everything and that the child really needs it,” she told TMR.
She said the next step would be talking with primary care colleagues including the Royal Australian College of General Practitioners to discuss the findings and whether it would be appropriate to revisit existing guidelines and treatment pathways.
While current pathways do not include the use of saline nasal spray, Professor Nixon said she hoped these discussions would happen sometime this year.
