By Anne Harding

NEW YORK (Reuters Health) – A thermoplastic heat-molded mandibular-advancement device (MAD) is non-inferior to a custom-made MAD for treating obstructive sleep apnea (OSA), a new two-month randomized trial shows.

“This is really a noninferiority message, for shorter treatment in moderate-to-severe sleep-apnea patients,” Dr. Jean Louis Pepin of Universite Grenoble Alpes in Saint-Martin-d’Heres, France, the study’s first author, told Reuters Health by phone. “In this condition, you can expect significant efficacy and an acceptable rate of side effects.”

The adjustable ONIRIS device used in the trial costs about $70-$100, Dr. Pepin noted, versus roughly $1,000 for the custom-made TALI device. Both devices are made by Oniris SAS (Reueil Malmaison, France).

MADs have been shown to be similarly effective to continuous positive airway pressure (CPAP), Dr. Pepin and his colleagues note in Thorax, online May 3. “Various different MAD designs currently exist and constantly emerge on the market without clear evidence regarding the best technical choice and the cost-effectiveness compromise,” they add.

While clinical guidelines recommend two-piece custom-made, titratable devices as the gold standard, they are costly and time-consuming to make, and titration procedures have not been standardized, the authors add. In addition, Dr. Pepin noted, the approach does not work in all patients.

“There is no guarantee compared to CPAP that this treatment is always effective, especially in obese patients or moderate to severe patients,” he said.

To investigate whether the off-the-shelf device could offer a cheaper, faster alternative, he and his colleagues enrolled 198 patients from eight sleep centers to use the TALI device or the ONIRIS device for two months.

The non-inferiority outcome was a 50% or greater drop in apnea-hypopnea index (AHI) or having fewer than 10 AHI events per hour.

TALI patients had a 51.7% response rate, compared to 53.6% in the ONIRIS group. The devices were similarly effective for improving severity, symptoms and quality of life and reducing blood pressure.

“We have an ongoing study looking at the effects at one year,” Dr. Pepin said. “For populations with low incomes it could be a really accessible treatment.”

In an editorial accompanying the study, Dr. Kate Sutherland of Royal North Shore Hospital in St. Leonards and Dr. Oyku Dalci of the University of Sydney, both in Australia, note that the biggest potential drawback to popularization of the adjustable devices is the lack of a dental check to determine if a patient is a suitable candidate.

“However, under dental supervision, this study shows short-term non-inferiority in efficacy rates to a customised comparator with good reported usage in that time frame,” they write.

Dr. Pepin and other study authors received honoraria from ONIRIS, which funded the trial.

Thorax 2019.