Children with the obstructive sleep apnea syndrome (OSAS) who undergo treatment with intranasal corticosteroids (INCS) did not experience significant improvement in polysomnographic, neurobehavioral, and other symptoms at 3 and 12 months of treatment. At 12 months of INCS treatment, there was a statistically significant but not clinically relevant reduction in the obstructive apnea hypopnea index (OHAI).
“Previous studies were done in children with OSA with an obstructive apnea hypopnea index of less than 5, so they had very mild OSA,” Ignacio Tapia, MD, associate professor of pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, explained to Medscape Medical News.
“But then people started using the INCS for a whole range of OSA, so this is why we wanted to do the trial, to make sure that these drugs were being used correctly,” he added.
“The main message from this paper is that I think INCS may still have a role to play in OSA to treat some of the symptoms, like snoring, and in our study, quality-of-life indices also improved, but physicians should not expect they will cure the OSA ― they may reduce some symptoms, but they will not reduce the OAHI,” Tapia emphasized.
The study was published online June 29 in Chest.
Three Months of INCS
A total of 134 children between 5 and 12 years of age were randomly assigned to receive INCS for 3 months or placebo. Children in the original INCS arm were then reassigned to receive 9 more months of the same treatment or placebo. Symptoms as well as polysomnographic and neurobehavioral findings were measured at baseline, at 3 months, and again at 12 months.
“The primary outcome was OAHI change at 3 months, available for 122 children,” the authors explain. The OSAS was defined as an OAHI of between two and three events per hour. The median age of the children at baseline was 7.9 years, and the median OAHI baseline score was 5.8/hr (95% CI, 3.6 – 9.7/hr). The total daily dose of the INCS used was 110 μg.
At 3 months, the mean change in the OAHI from baseline was -1.73/hr (95% CI, -3.91 to 1.92/hr), while at 12 months, the mean change in the same index was -1.21 (-4.22 to 1.71/hr). These changes were not significantly different from OAHI changes observed among control participants. “OSAS symptoms and neurobehavioral results were not different [either] between the INCS and placebo groups at 3 and12 months,” the authors add.
However, among those children who received INCS treatment for the entire 12 months, the OAHI decreased significantly from 7.2/hr (95% CI, 3.62 – 9.88/hr) at baseline to 3.71/hr (95% CI, 1.56 – 6.4/hr; P = .039), although the OAHI did not normalize, the authors note. Asked to clarify whether this change was not significant, Tapia said that it did meet statistical significance, but clinically, it meant that the children still needed some form of treatment, because they still had OSA in the range needing treatment.
The placebo group had more asthma exacerbations, upper respiratory tract infections, and exacerbations of OSAS symptoms compared to children in the INCS group. It is possible that INCS provided a certain degree of protection from asthma exacerbation, the authors suggest.
However, recent guidelines from the American Academy of Pediatrics suggest that clinicians may prescribe these agents for children with mild OSAS in whom adenotonsillectomy is contraindicated; for those with mild postoperative OSAS, adenotonsillectomy remains the treatment of choice for childhood OSA. “The low level of enthusiasm for INCS in these guidelines is based on results from studies of INCS treatment of OSAS that had been limited by small sample size, lack of placebo control, limited duration and variability in baseline data,” the authors state.
“The results of the current larger and more rigorous study of children with a wider range of OSAS also do not support the currently liberal use of INCS for the treatment of OSAS,” they reemphasize.
Asked by Medscape Medical News to comment on the findings, Rakesh Bhattacharjee, MD, associate professor of pediatrics, University of California, San Diego, noted that he does prescribe INCS for children with mild OSA but not for all children. “We based our decisions on polysomnography, which we use to categorize OSA as mild, moderate, or severe,” he cautioned.
“But we certainly do offer this treatment for children with mild sleep apnea as a way to avoid surgical treatment,” Bhattacharjee added. He also uses INCS for residual sleep apnea that some children experience following adenotonsillectomy. As the current study suggests, many people are treating sleep apnea empirically without confirming the severity of the disorder by a sleep study.
“If a sleep study is not done, we don’t know how severe it is, so this would advocate for the utility of a sleep study so that you can quantify the severity of symptoms and target your therapy to children who might be appropriate for INCS therapy,” Bhattacharjee said.
On the other hand, surgery is not always relevant even if a child has enlarged adenoids and tonsils, as, for example, a child with obesity. In these children, physicians need to think about other treatments, such as continuous positive airways pressure (CPAP). “CPAP is not perfect,” Bhattacharjee observed. “And as pediatricians, we need to do a lot of work to improve the use of CPAP, but, that said, there are children for whom INCS and surgery might be a waste of time, and this is where CPAP might be an alternative,” he said.
Bhattacharjee previously was the lead author of a large study of children who underwent treatment with CPAP. While findings suggested that adherence to treatment is lower in children than it is for adults, the authors also showed that numerous actionable factors could used to improve adherence to CPAP among children who might otherwise benefit from it.
The authors have disclosed no relevant financial relationships. Bhattacharjee has served as a scientific advisor for Jazz Pharmaceuticals.
Chest. Published online June 29, 2022. Abstract
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