TY - JOUR T1 - Late Breaking Abstract - Effect of custom made vs thermoplastic heat-molded mandibular advancement devices (MADs) for Obstructive Sleep Apnea (OSA): A randomized non-inferiority trial JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/1393003.congress-2017.PA322 VL - 50 IS - suppl 61 SP - PA322 AU - Thibault Vincent AU - Jean-Louis Pepin AU - Nathalie Raymond AU - Olivier Lacaze AU - Nathalie Aisenberg AU - JéRôMe Forcioli AU - Eric Bonte AU - Arnaud Bourdin AU - Sandrine Launois AU - Renaud Tamisier AU - Nicolas Molinari Y1 - 2017/09/01 UR - http://erj.ersjournals.com/content/50/suppl_61/PA322.abstract N2 - 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. ER -