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

Abstract

Rationale: 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.

Objectives: 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.

Methods: 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.

Measurements and main results: 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.

Conclusions: 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.