ATLANTA -- Balloon catheter dilation yielded no improvement for obstructive sleep apnea patients with sinus pressure headache, a small prospective single-blind study found.
The group randomized to dilation of the sinus ostia had a mean decrease of 2.11 in apnea-hypopnea index from pre- to post-treatment, which was not significantly different than the decrease of 2.04 in the control arm of placebo nasal dilation (P=0.89), Alexandra S. Ortiz, MD, of the San Antonio Uniformed Services Health Education Consortium, reported.
Similarly, the mean change in lowest oxygen saturation was similar between the two groups: a 1% increase in the active-treatment group compared with a 0.5% decline in the nasal dilation group (P=0.89), according to the findings presented here at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) meeting.
The results are consistent with a recent that balloon catheter dilation of sinus ostia is not an effective treatment for sleep apnea in patients without sinus disease.
The typical first-line management of obstructive sleep apnea in adults is continuous positive airway pressure (CPAP), but up to 50% of patients cannot tolerate or are not adherent to CPAP therapy, Ortiz said.
Balloon catheter dilation received FDA approval in 2005 for the treatment of chronic rhinosinusitis. Since then, it has been marketed for other indications such as snoring, obstructive sleep apnea, and headaches, despite lacking evidence of efficacy for these indications, said Ortiz.
"You can find on multiple practice's websites that it's being done for those indications ... and the Department of Defense's database showed that a significant number of clinicians were using balloon dilation for indications other than chronic rhinosinusitis," she told app.
The AAO-HNSF consensus statement, issued in February 2018, indicates that balloon catheter dilation is not appropriate for patients without both sinonasal symptoms and positive findings on computed tomography (CT), nor for the management of headache or sleep apnea in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis.
Further, CT scanning of the sinuses is required before balloon dilation can be performed; patients with sinonasal symptoms and a CT that does not show evidence of sinonasal disease should not undergo balloon catheter dilation, according to the AAO-HNSF recommendation.
For the current study, Ortiz's group randomized 18 patients who were part of a larger study evaluating maxillary balloon catheter dilation on patients with symptoms of sinus pressure headache, but no evidence of sinus mucosal thickening on CT. All 18 patients had home polysomnography performed before and after balloon catheter dilation.
Subjective measures of sleep quality were also performed. On the Berlin questionnaire, there was no significant difference in the change from baseline in the total, category 1, or category 2 scores in either group. Snoring visual analog scale (VAS) scores were not different compared with baseline at 2 weeks (P=0.38), 3 months (P=0.19), and 6 months (P=0.47) after the procedure.
"These results show that sinus balloon catheter dilation does not improve important metrics of obstructive sleep apnea severity when compared to placebo," said Ortiz. "Berlin questionnaire and VAS results show that sleep quality and snoring are also unaffected by maxillary balloon catheter dilation."
Disclosures
Ortiz reported no disclosures.
Primary Source
American Academy of Otolaryngology-Head and Neck Surgery Foundation
Ortiz AS, et al “Effects of balloon catheter dilation of sinus ostia on obstructive sleep apnea and snoring” AAO-HNSF 2018.