Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial.,The Lancet Respiratory Medicine

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Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial.
The Lancet Respiratory Medicine ( IF 38.7 ) Pub Date : 2019-12-02 , DOI: 10.1016/s2213-2600(19)30402-3
Alison J Wimms ₁ , Julia L Kelly ₂ , Christopher D Turnbull ₃ , Alison McMillan ₄ , Sonya E Craig ₅ , John F O'Reilly ₅ , Annabel H Nickol ₆ , Emma L Hedley ₇ , Meredith D Decker ₈ , Leslee A Willes ₈ , Peter M A Calverley ₉ , Adam V Benjafield ₁₀ , John R Stradling ₃ , Mary J Morrell ₂ ,

Affiliation

Background

The evidence base for the treatment of mild obstructive sleep apnoea is limited and definitions of disease severity vary. The MERGE trial investigated the clinical effectiveness of continuous positive airway pressure in patients with mild obstructive sleep apnoea.

Methods

MERGE, a multicentre, parallel, randomised controlled trial enrolled patients (≥18 years to ≤80 years) with mild obstructive sleep apnoea (apnoea-hypopnoea index [AHI] ≥5 to ≤15 events per h using either AASM 2007 or AASM 2012 scoring criteria) from 11 UK sleep centres. Participants were assigned (1:1) to either 3 months of continuous positive airway pressure plus standard care (sleep counselling), or standard care alone, by computer-generated randomisation; neither participants nor researchers were blinded. The primary outcome was a change in the score on the Short Form-36 questionnaire vitality scale in the intention-to-treat population of patients with mild obstructive sleep apnoea diagnosed using the American Academy of Sleep Medicine 2012 scoring criteria. The study is registered with ClinicalTrials.gov, NCT02699463.

Findings

Between Nov 28, 2016 and Feb 12, 2019, 301 patients were recruited and randomised. 233 had mild obstructive sleep apnoea using AASM 2012 criteria and were included in the intention-to-treat analysis: 115 were allocated to receive continuous positive airway pressure and 118 to receive standard care. 209 (90%) of these participants completed the trial. The vitality score significantly increased with a treatment effect of a mean of 10·0 points (95% CI 7·2–12·8; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (9·2 points [6·8 to 11·6] vs −0·8 points [–3·2 to 1·5]). Using the ANCOVA last-observation-carried-forward analysis, a more conservative estimate, the vitality score also significantly increased with a treatment effect of a mean of 7·5 points (95% CI 5·3 to 9·6; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (7·5 points [6·0 to 9·0] vs 0·0 points [–1·5 to 1·5]). Three serious adverse events occurred (one allocated to the continuous positive airway pressure group) and all were unrelated to the intervention.

Interpretation

3 months of treatment with continuous positive airway pressure improved the quality of life in patients with mild obstructive sleep apnoea. These results highlight the need for health-care professionals and providers to consider treatment for patients with mild obstructive sleep apnoea.

Funding

ResMed Ltd.

中文翻译：

持续的气道正压通气与标准护理治疗轻度阻塞性睡眠呼吸暂停（MERGE）的患者：一项多中心，随机对照试验。

背景

治疗轻度阻塞性睡眠呼吸暂停的证据基础有限，疾病严重程度的定义也有所不同。MERGE试验研究了轻度阻塞性睡眠呼吸暂停患者持续气道正压通气的临床效果。

方法

MERGE，一项多中心，平行，随机对照试验，采用AASM 2007或AASM 2012评分法，对轻度阻塞性睡眠呼吸暂停（呼吸暂停-呼吸不足指数[AHI]每小时≥5至≤15事件）的患者（≥18岁）进行了研究标准）来自11个英国睡眠中心。通过计算机生成的随机分组将参与者分配为（1：1）3个月的持续气道正压加标准护理（睡眠咨询），或单独进行标准护理；参与者和研究人员都没有致盲。主要结果是使用美国睡眠医学学会2012年评分标准诊断的轻度阻塞性睡眠呼吸暂停患者的意向性治疗人群的Short Form-36问卷活力量表得分的变化。该研究已在ClinicalTrials.gov上注册，NCT02699463。

发现

在2016年11月28日至2019年2月12日之间，共招募了301名患者并随机分组。根据AASM 2012标准，有233例患有轻度阻塞性睡眠呼吸暂停，被纳入意向性治疗分析：115例接受持续的气道正压通气，118例接受标准护理。这些参与者中有209位（占90％）完成了试验。与单独标准治疗相比，连续3个月的持续气道正压通气治疗后，生命力评分显着提高，平均治疗效果为10·0分（95％CI 7·2–12·8； p <0·0001）（ 9·2分[6·8至11·6]对−0·8点[–3·2至1·5]）。使用ANCOVA最后观察进行的分析，更保守的估计，生命力评分也显着提高，平均治疗效果为7·5分（95％CI 5·3至9·6； p <0连续3个月的持续气道正压通气后，与单独的标准护理（7·5分[6·0至9·0]和0·0分[–1·5至1·5]）相比。发生了三起严重的不良事件（一项被分配为持续气道正压通气组），并且与干预措施无关。