Continuous Positive Airway Pressure and Mandibular Advancement Splints: The CHOICE Multi-center Open-Label Randomized Clinical Trial.

Abstract

Adherence to Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnoea (OSA) continues to be low with high termination rates. Alternative therapies to CPAP are needed. To compare objective adherence to CPAP and Mandibular Advancement Splints (MAS) and to evaluate their effectiveness. Additionally, to identify treatment usage patterns and the clinical effectiveness of having both therapies. This multi-center, double-randomized, three-phase trial (titration/cross-over/observation) was conducted at three Canadian universities. Eligible participants were treatment-naïve with mild to severe OSA. Primary outcome was objectively measured adherence (hours/night) during cross-over phase. Secondary outcomes included efficacy during cross-over phase; adherence during observational phase; patient-centered outcomes, blood pressure and side-effects during cross-over and observational phases. Duration of cross-over and observational phases were 2.5 and 6 months respectively.Eighty-one participants were enrolled in the first randomization. Seventy-nine entered the adaptation/titration phase [mean age (sd); 52·3 (10·8) years, 58 males], 73 entered the cross-over phase (included in the intention-to-treat analysis) and 64 completed the observation phase. Mean objective adherence over 1-month, MAS showed higher adherence than CPAP, 6·0 versus 5·3 h/night (difference= 0·7 h/night, 95% CI: 0·3-1·2 h, p<0·001). Mean CPAP-MAS difference (95% CI) in efficacy of 10·4 (7·8-13) events/hour, p<0·001. During the observation phase 55% (35/64) of participants chose to alternate therapies. All treatments led to substantial improvement in patient-centered outcomes. Despite the higher efficacy of CPAP and higher adherence to MAS, both demonstrate comparable clinical effectiveness on patient-centered outcomes. Having both CPAP and MAS can improve long-term management of OSA.