Hamoda Mona M, Huynh Nelly, Ayas Najib T, Rompré Pierre, Bansback Nick, Masse Jean-François, Arcache Patrick, Lavigne Gilles, Series Frederic, Fleetham John A, Almeida Fernanda R
Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, Vancouver, BC, Canada
Faculty of Dentistry, Université de Montréal, Montreal, QC, Canada.
Eur Respir J. 2025 Apr 3;65(4). doi: 10.1183/13993003.01100-2024. Print 2025 Apr.
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. 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.
This multicentre, double-randomised, three-phase trial (titration/crossover/observation) was conducted at three Canadian universities. Eligible participants were treatment-naïve with mild-to-severe OSA. The primary outcome was objectively measured adherence (hours per night) during the crossover phase. 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. Duration of the crossover and observational phase was 2.5 and 6 months, respectively.
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-treat analysis) and 64 completed the observational phase. Mean objective adherence over 1 month: MAS showed higher adherence than CPAP, 6.0 5.3 h·night (difference 0.7 (95% CI 0.3-1.2) h·night; p<0.001). Mean CPAP-MAS difference in efficacy: 10.4 (95% CI 7.8-13.0) events·h; p<0.001. During the observational phase 55% (35 out of 64) of participants chose to alternate therapies. All treatments led to substantial improvement in patient-centred outcomes.
Despite the higher efficacy of CPAP and higher adherence to MAS, both demonstrate comparable clinical effectiveness on patient-centred outcomes. Having both CPAP and MAS can improve long-term management of OSA.
阻塞性睡眠呼吸暂停（OSA）患者对持续气道正压通气（CPAP）的依从性仍然较低，终止率较高。需要CPAP的替代疗法。我们的目的是比较CPAP和下颌前移矫治器（MAS）的客观依从性，评估它们的有效性，并另外确定治疗使用模式以及两种疗法的临床疗效。
这项多中心、双随机、三阶段试验（滴定/交叉/观察）在三所加拿大大学进行。符合条件的参与者为初治的轻至重度OSA患者。主要结局是在交叉阶段客观测量的依从性（每晚小时数）。次要结局包括交叉阶段的疗效；观察阶段的依从性；以及以患者为中心的结局、交叉阶段和观察阶段的血压及副作用。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。
81名参与者进行了首次随机分组。79人进入适应/滴定阶段（平均±标准差年龄52.3±10.8岁；58名男性），73人进入交叉阶段（纳入意向性分析），64人完成观察阶段。1个月内的平均客观依从性：MAS的依从性高于CPAP，分别为每晚6.0对5.3小时（差异0.7（95%CI 0.3 - 1.2）小时/晚；p<0.001）。CPAP与MAS疗效的平均差异：10.4（95%CI 7.8 - 13.0）次事件/小时；p<0.001。在观察阶段，55%（64人中的35人）的参与者选择交替使用两种疗法。所有治疗均使以患者为中心的结局有显著改善。
尽管CPAP疗效更高且对MAS的依从性更高，但两者在以患者为中心的结局方面显示出相当的临床疗效。同时拥有CPAP和MAS可改善OSA的长期管理。
