Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
Medical Research Council Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge, UK.
Thorax. 2014 Oct;69(10):938-45. doi: 10.1136/thoraxjnl-2014-205464. Epub 2014 Jul 17.
Mandibular advancement devices (MADs) are used to treat obstructive sleep apnoea-hypopnoea syndrome (OSAHS) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease.
To compare clinical- and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS.
This open-label, randomised, controlled, crossover trial was undertaken at a UK sleep centre. Adults with Apnoea-Hypopnoea Index (AHI) 5-<30/h and Epworth Sleepiness Scale (ESS) score ≥9 underwent 6 weeks of treatment with three non-adjustable MADs: self-moulded (SleepPro 1; SP1); semi-bespoke (SleepPro 2; SP2); fully-bespoke MAD (bMAD); and 4 weeks no treatment. Primary outcome was AHI scored by a polysomnographer blinded to treatment. Secondary outcomes included ESS, quality of life, resource use and cost.
90 patients were randomised and 83 were analysed. All devices reduced AHI compared with no treatment by 26% (95% CI 11% to 38%, p=0.001) for SP1, 33% (95% CI 24% to 41%) for SP2 and 36% (95% CI 24% to 45%, p<0.001) for bMAD. ESS was 1.51 (95% CI 0.73 to 2.29, p<0.001, SP1) to 2.37 (95% CI 1.53 to 3.22, p<0.001, bMAD) lower than no treatment (p<0.001 for all). Compliance was lower for SP1, which was the least preferred treatment at trial exit. All devices were cost-effective compared with no treatment at a £20,000/quality-adjusted life year (QALY) threshold. SP2 was the most cost-effective up to £39,800/QALY.
Non-adjustable MADs achieve clinically important improvements in mild to moderate OSAHS and are cost-effective. Of those trialled, the semi-bespoke MAD is an appropriate first choice.
ISRCTN02309506.
下颌前移装置（MADs）用于治疗阻塞性睡眠呼吸暂停低通气综合征（OSAHS），但在疾病较轻的情况下，其临床和成本效益证据不足。
比较一系列 MADs 与不治疗在轻度至中度 OSAHS 中的临床和成本效益。
这是一项在英国睡眠中心进行的开放标签、随机、对照、交叉试验。呼吸暂停低通气指数（AHI）为 5-<30/小时和嗜睡量表（ESS）评分≥9 的成年人接受了 6 周的三种非调节 MADs 治疗：自塑型（SleepPro 1；SP1）；半定制（SleepPro 2；SP2）；全定制 MAD（bMAD）；和 4 周不治疗。主要结局是由对治疗不知情的多导睡眠图记录者记录的 AHI。次要结局包括 ESS、生活质量、资源利用和成本。
90 名患者被随机分组，83 名患者进行了分析。与不治疗相比，所有设备均使 AHI 降低了 26%（95%CI 11%至 38%，p=0.001），SP1 为 33%（95%CI 24%至 41%），SP2 为 36%（95%CI 24%至 45%，p<0.001），bMAD 为 36%（95%CI 24%至 45%，p<0.001）。ESS 降低了 1.51（95%CI 0.73 至 2.29，p<0.001，SP1）至 2.37（95%CI 1.53 至 3.22，p<0.001，bMAD），与不治疗相比（所有均<0.001）。SP1 的依从性较低，这是试验结束时最不受欢迎的治疗方法。所有设备与不治疗相比，在 £20,000/质量调整生命年（QALY）阈值上均具有成本效益。SP2 在 £39,800/QALY 之前是最具成本效益的。
非调节 MADs 可在轻度至中度 OSAHS 中获得显著的临床改善，并且具有成本效益。在试验中，半定制 MAD 是一个合适的首选。
ISRCTN02309506。
