Continuous positive airway pressure and mandibular advancement splints: the CHOICE multicentre, open-label randomised clinical trial.

Alternative therapies to CPAP are needed.

需要寻找替代CPAP的治疗方法。

Our objective was to compare objective adherence to CPAP and mandibular advancement splints (MAS) and to evaluate their effectiveness, and additionally to identify treatment usage patterns and the clinical effectiveness of having both therapies.

我们的目标是比较持续气道正压通气(CPAP)和下颌前移装置(MAS)的客观依从性，并评估它们的有效性，此外，还要识别治疗使用模式以及两种治疗方法的临床效果。

Methods

This multicentre, double-randomised, three-phase trial (titration/crossover/observation) was conducted at three Canadian universities.

这项多中心、双随机、三阶段试验（调整/交叉/观察）在加拿大的三所大学进行。

Eligible participants were treatment-naïve with mild-to-severe OSA.

符合条件的参与者是未经治疗的轻度至重度睡眠呼吸暂停低通气综合征（OSA）患者。

The primary outcome was objectively measured adherence (hours per night) during the crossover phase.

主要结果是在交叉阶段客观测量的依从性（每晚小时数）。

Secondary outcomes included efficacy during the crossover phase; adherence during the observational phase; and patient-centred outcomes, blood pressure and side-effects during the crossover and observational phases.

次要结果包括交叉阶段的疗效；观察阶段的依从性；以及患者中心的结果，包括交叉和观察阶段的血压和副作用。

Duration of the crossover and observational phase was 2.5 and 6 months, respectively.

交叉阶段和观察阶段的持续时间分别为2.5个月和6个月。

Results

81 participants were enrolled in the first randomisation. 79 entered the adaptation/titration phase (mean±sd age 52.3±10.8 years; 58 males), 73 entered the crossover phase (included in the intention-to-treatanalysis) and 64 completed the observational phase.

首次随机分组中，共有81名参与者被纳入。其中79人进入了适应/滴定阶段（平均年龄52.3±10.8岁；58名为男性），73人进入了交叉阶段（纳入意向治疗分析），最终64人完成了观察阶段。

Mean objective adherence over 1 month: MAS showed higher adherence than CPAP, 6.0 versus 5.3 h·night-1 (difference 0.7 (95% CI 0.3-1.2) h·night-1; p<0.001).

1个月的平均客观依从性：MAS显示出比CPAP更高的依从性，6.0比5.3小时/晚（差异0.7（95%置信区间0.3-1.2）小时/晚；p<0.001）。

Mean CPAP-MAS difference in efficacy: 10.4 (95% CI 7.8-13.0) events·h-1; p<0.001.

CPAP与MAS疗效平均差异：10.4 (95% 置信区间 7.8-13.0) 次·小时-1；p<0.001。

During the observational phase 55% (35 out of 64) of participants chose to alternate therapies.

在观察阶段，55%（64名参与者中的35名）选择交替使用不同治疗方法。

All treatments led to substantial improvement in patient-centred outcomes.

所有治疗方案均显著改善了以患者为中心的治疗结果。

Conclusions

Despite the higher efficacy of CPAP and higher adherence to MAS, both demonstrate comparable clinical effectiveness on patient-centred outcomes.

尽管持续气道正压通气（CPAP）的疗效更高，且对多导睡眠图（MAS）的依从性更好，但两者在以患者为中心的治疗结果上显示出相当的临床效果。

Having both CPAP and MAS can improve long-term management of OSA.

同时使用持续气道正压通气（CPAP）和口腔矫治器（MAS）可以改善阻塞性睡眠呼吸暂停（OSA）的长期管理。