Novel oral appliances safe, improve OSA severity

Key takeaways:

• Day and night appliance use and mandibular-repositioning nighttime appliance use each improved disease severity among those with severe OSA.
• Patients with severe vs. moderate disease had more improvements.

HONOLULU — Apnea-hypopnea index, transpalatal width and airway volume all improved with use of an oral appliance in patients with severe obstructive sleep apnea, according to research presented at the CHEST Annual Meeting.

“This study did show that severe OSA can be improved with oral appliances,” Clete A. Kushida, MD, PhD, neurologist, professor of psychiatry and behavioral sciences, and chief and medical director of the division of sleep medicine at Stanford University School of Medicine, said during his presentation. “We also showed that for patients diagnosed with severe OSA, it was safe and effective, as it was for moderate OSA patients as well.”

In a retrospective analysis, Kushida and colleagues assessed 39 adults with severe OSA (mean age, 56.9 years; 20 men) and 35 adults with moderate OSA (mean age, 48.9 years; 15 men) to compare the impacts of a day and night appliance (DNA) and a mandibular-repositioning nighttime appliance (mRNA; both Vivos Therapeutics) — used for at least 10 hours a day — on apnea-hypopnea index (AHI), transpalatal width and airway volume between the two disease severity levels.

The mRNA is made up of a DNA device and a mandibular advancement device, Kushida said during his presentation.

Kushida also indicated that both mRNA and DNA devices should be used for 6 to 24 months if patients want to achieve a larger upper airway volume and lower the severity of their OSA. Notably, the FDA has cleared both the DNA device and the mRNA device for those with mild to moderate OSA.

Among those with severe OSA, 17 used mRNA and 22 used DNA, whereas 12 used mRNA and 23 used DNA in the moderate OSA group. Researchers saw a slightly longer treatment duration among adults with severe vs. moderate OSA (14.8 months vs. 12.3 months) but self-reported appliance adherence was the same in both groups (12.4 hours).

Average BMI did differ between the groups, with the severe OSA group having a higher BMI both before and after treatment compared with the moderate OSA group (severe OSA, 30 kg/m² and 30.7 kg/m² vs. moderate 25 kg/m² and 25 kg/m²).

All three outcomes improved when comparing data from before and after treatment in both patients with severe OSA and moderate OSA; however, researchers observed larger percentage changes among those with severe OSA.

Importantly, all data taken before and after treatment were done without the oral appliance in place, Kushida said.

In the severe OSA group, the percentage change in AHI was –50.1%, whereas the moderate OSA group had a change of –44.4%. Transpalatal width improved by 7.1% among those with severe OSA and 6.6% among those with moderate OSA. Lastly, airway volume went up by 22.4% in the severe OSA group, which was higher than the 12.8% increase seen in the moderate OSA group.

Kushida added that they found no significant safety issues.

Further, when comparing both devices, researchers found more improvement in AHI with the DNA device vs. the mRNA device in both those with severe OSA (percent change before to after treatment, –52.8% vs. –49.2%) and those with moderate OSA (–47.6% vs. –38.5%).

“Importantly, the DNA and mRNA appliances are an advancement over conventional oral appliances since they modify the upward [airway] predominately via maxillary expansion, and it appears that these treatment effects persist without the appliance in place," Kushida said.