BACKGROUND Obstructive sleep apnoea (OSA) and morbid obesity (MO), defined by a body mass index ≥35 kg/m2, are two closely related conditions. Recent studies suggest that circulating microRNA (miRNA) plays a potential role in the physiopathology of both conditions. To date, circulating miRNA expression has been studied separately in both conditions, but never jointly. The primary treatment of OSA is continuous positive airway pressure (CPAP), whereas bariatric surgery (BS) is the treatment of choice for MO. We have thus initiated the Epigenetics modification in Morbid Obesity and Obstructive Sleep Apnoea (EPIMOOSA) study (ClinicalTrials.gov identifier: NCT03995836). METHODS/DESIGN EPIMOOSA is a prospective non-interventional cohort study aiming to recruit 45 MO patients who are candidates for BS. Three groups will be formed: MO without OSA, MO with OSA without CPAP and MO with OSA and CPAP. All of them will be followed up in 4 visits: baseline, 6 months prior to BS and 3, 6 and 12 months post-BS. At baseline, OSA status will be assessed by home sleep polygraphy (HSP), and CPAP will be adopted according to national guidelines. A specific standardized questionnaire (including medical conditions and AOS-related symptoms) and anthropometrical examination will be performed at each visit. Blood samples will be obtained at each visit for immediate standard biochemistry, haematology and inflammatory cytokines. For bio-banking, serum, plasma, and circulating exosomes will also be obtained. Twenty-four hours of blood pressure and electrocardiogram (ECG) Holter monitoring will be performed at all visits. A new HSP will be performed at the last visit. Finally, the three groups will be sex- and age- matched with participants in the EPIOSA study, an ongoing study aimed at understanding epigenetic changes in non-obese OSA patients. DISCUSSION EPIMOOSA will evaluate changes in circulating miRNA in MO with or without OSA for the first time. In addition, EPIMOOSA will be able to elucidate the influence of OSA in MO patients and how specific and combined treatments alter miRNA expression.

中文翻译：

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有或没有阻塞性睡眠呼吸暂停的病态肥胖的表观遗传功能障碍：EPIMOOSA研究。

背景技术由体重指数≥35kg / m2定义的阻塞性睡眠呼吸暂停（OSA）和病态肥胖（MO）是两个密切相关的疾病。最近的研究表明，循环中的microRNA（miRNA）在这两种情况的生理病理中均起着潜在的作用。迄今为止，已经在两种条件下分别研究了循环miRNA的表达，但从未联合研究过。OSA的主要治疗方法是持续气道正压通气（CPAP），而减肥手术（BS）是MO的治疗选择。因此，我们启动了病态肥胖和阻塞性睡眠呼吸暂停（EPIMOOSA）研究的表观遗传学修饰（ClinicalTrials.gov标识符：NCT03995836）。方法/设计EPIMOOSA是一项前瞻性非干预性队列研究，旨在招募45名适合BS的MO患者。将形成三个组：没有OSA的MO，使用OSA和CPAP的MO以及使用OSA和CPAP的MO。将在4次随访中对所有患者进行随访：基线，BS之前6个月以及BS之后3、6和12个月。在基线时，将通过家庭睡眠测谎仪（HSP）评估OSA状态，并将根据国家指南采用CPAP。每次访视时将进行特定的标准化问卷（包括医疗状况和与AOS相关的症状）和人体测量学检查。每次就诊都将获得血样，用于即时标准生物化学，血液学和炎性细胞因子。对于生物储备，还将获得血清，血浆和循环外泌体。所有访视都会进行24小时血压和心电图（ECG）动态心电图监测。最后一次访问将执行新的HSP。最后，这三组患者的性别和年龄均与EPIOSA研究的参与者匹配，这项正在进行的研究旨在了解非肥胖OSA患者的表观遗传学变化。讨论EPIMOOSA将首次评估有或没有OSA的MO中循环miRNA的变化。此外，EPIMOOSA将能够阐明OSA对MO患者的影响以及特异性和联合治疗如何改变miRNA的表达。