Intranasal Saline Proves Effective for Children's Sleep Apnea

For children with obstructive sleep apnea, repeating 6-week courses of intranasal saline resolved symptoms for many and performed similarly to switching to an intranasal steroid for persistent cases, the randomized MIST+ trial showed. An initial 6-week course of intranasal saline resolved symptoms for 29.5% of 3- to 12-year-olds with obstructive sleep-disordered breathing (OSDB), reported Gillian M. Nixon, MD, of Melbourne Children's Sleep Centre in Australia, and colleagues in JAMA Pediatrics. For those with persistent symptoms, randomization to a further 6 weeks of intranasal saline led to another 35.6% becoming symptom-free compared with 36.4% who were randomized to an intranasal steroid instead. The difference between the two didn't meet clinical or statistical significance (risk difference -0.9%, 95% CI -20.7 to 19.0, P=0.93). "Intranasal saline is an effective short-term first-line treatment for OSDB before consideration of polysomnography or surgical intervention," the researchers concluded. Intranasal steroids have been part of the treatment pathway for children with OSDB for more than 20 years based on small randomized controlled trials, whereas nasal rinses have been largely tested and proven in the rhinitis setting. The prior MIST trial extended that proof to treatment of OSDB. When children were randomized to intranasal saline or intranasal steroids for an initial 6-week round of treatment, both groups had about 40% resolution of symptoms, "suggesting that saline is not an inert placebo," Nixon and colleagues wrote. The MIST+ findings "confirmed that saline alone is effective as a first-line treatment, and even after not responding after 6 weeks of treatment, another one-third of children responded to a further 6 weeks of intranasal saline, similar numbers to [intranasal steroids]," they added. "We propose that saline should be recommended for 3 months before assessing the need for specialist referral." Following such a strategy would reduce demand for specialist services, they noted. "Effective management in primary care is ideal so that symptoms can be rapidly addressed, allowing specialist services such as sleep medicine and otolaryngology to focus on those with severe or persistent disease." MIST+ included 150 children ages 3-12 years (mean age 6.2, 62% male) who had been referred to a specialist at one of two tertiary children's hospitals in Australia for significant OSDB symptoms, including frequent snoring and at least one other obstructive sleep apnea symptom in accord with the American Academy of Pediatrics' guideline for diagnosis. The study didn't include children with a prior surgery on the tonsils, adenoids, or nasal passages; a body mass index above the 97th centile; active tonsil or nasal infection; or recent use of corticosteroids or montelukast (Singulair). All children received one spray of 0.9% sodium chloride (normal saline) per nostril per day for a 6-week run-in period, after which 29.5% had resolution of symptoms. The rest received random assignment to double-blind treatment with another 6 weeks of intranasal saline or once-daily intranasal mometasone furoate (50 μg). The combined symptom resolution rate with intranasal saline between the run-in and treatment phase was about 50%. There were no differences in the secondary outcomes of parental perception of the need for surgery for OSDB and satisfaction with treatment at 6 weeks from the end of the run-in phase. The proportion of parents who reported that their child needed surgery slightly declined from enrollment to the end of the run-in phase (64.5% to 56.3%), as did the proportion who reported that a specialist appointment was required (92.9% to 89.4%). While "parents perceived a very small benefit of the spray" at that point, persistent symptom resolution was observed in 76.3% and 64.9% of children at their 6- and 12-week follow-up visits, respectively. In the treatment phase, satisfaction was similar for the steroid and saline groups (OR 0.64, 95% CI 0.30-1.37). However, sustained efficacy in terms of resolution of symptoms at 12 weeks from the beginning of randomized treatment was lower for the steroid group (20.0% vs 35.7%), although this was not statistically significant. The proportion of parents who perceived need for surgery or a specialist appointment at the 12-week visit was also similar. Subgroup analysis did not reveal a group more or less likely to respond to medical treatment, whether by age or risk factors at baseline, including tonsillar hypertrophy, allergic rhinitis, obesity, and severity of OSDB symptoms, "suggesting that saline has the potential to benefit all children with OSDB symptoms," Nixon and team wrote. The lack of a placebo group to assess spontaneous resolution of symptoms was a study limitation, although the researchers deemed such an occurrence unlikely in these children who typically had symptoms for years before enrollment.