Abstract
Background: Custom-made MADs are reported as providing higher efficacy rates compared to thermoplastic heat-molded MADs but at the price of higher costs and treatment delays. Objective: To determine if a thermoplastic heat-molded adjustable MAD (ONIRISTM) is noninferior to a custom made acrylic MAD (TALITM) in OSA.
Methods: We conducted a multicenter, single-blind, randomized controlled trial in OSA patients refusing or not tolerating CPAP. Participants were randomly assigned to a thermoplastic heat-molded adjustable MAD or a custom made acrylic MAD for 2 months with a stratification by center and OSA severity. The non-inferiority primary effectiveness outcome was a composite rate of success defined by a 50% reduction in apnea-hypopnea index (AHI) or an AHI<10/hour. The noninferiority margin was defined as a difference between groups of 20% for the primary outcome and assessed in per protocol analysis. Secondary outcomes included side effects.
Results: Of 198 patients (mean age 51 [SD, 12] years; 138 [72.6%] men; mean BMI 26 [SD, 2.7]kg/m2; mean AHI 26.6/hour [SD, 10.4]), 100 received TALITM and 98 ONIRISTM. Fifty two percent (51.7%) in the TALITM group vs 53.6% in the ONIRISTM groups were successfully treated for OSA (absolute difference, 2; 90%CI, -11 to 15 within the noninferiority margin). ONIRISTM group patients reported more frequently excessive salivation (P<0.01) and gag reflex (P<0.01) but compliance rates and treatment drop outs were the same in the two arms.
Conclusion: In OSA patients refusing or not tolerating CPAP, a thermoplastic heat-molded adjustable MAD (ONIRISTM) was noninferior to a custom made acrylic MAD.
- Copyright ©the authors 2017
