Centre for Clinical, Oral and Translational Sciences, King's College London, London, UK
School of Medicine, University College Dublin, Dublin, Ireland.
BMJ Open. 2023 Aug 24;13(8):e076661. doi: 10.1136/bmjopen-2023-076661.
Just under half of patients with obstructive sleep apnoea (OSA) also have gastro-oesophageal reflux disease (GORD). These conditions appear to be inter-related and continual positive airway pressure (CPAP) therapy, the gold standard treatment for OSA to prevent airway collapse, has been shown to reduce GORD. As the impact of mandibular advancement devices, a second-line therapy for OSA, on GORD has yet to be investigated, a feasibility study is needed prior to a definitive trial.
This will be a single-centre, single-blinded, tertiary-care based, interdisciplinary, parallel randomised controlled study. Potential OSA participants presenting to the sleep department will be pre-screened for GORD using validated questionnaires, consented and invited to receive simultaneous home sleep and oesophageal pH monitoring. Those with confirmed OSA and GORD (n=44) will be randomly allocated to receive either CPAP (n=22) or MAD therapy (n=22). Following successful titration and 3 weeks customisation period, participants will repeat the simultaneous sleep and oesophageal pH monitoring while wearing the device. The number of patients screened for recruitment, drop-out rates, patient feedback of the study protocol, costs of interventions and clinical information to inform a definitive study design will be investigated.
Health Research Authority approval has been obtained from the Nottingham 2 Research Ethics Committee, ref:22/EM/0157 and the trial has been registered on ISRCTN (https://doi.org/10.1186/ISRCTN16013232). Definitive findings about the feasibility of doing 24 hour pH oesophageal monitoring while doing a home sleep study will be disseminated via clinical and research networks facilitating valuable insights into the simultaneous management of both conditions.
ISRCTN Reg No: 16013232.
约半数阻塞性睡眠呼吸暂停（OSA）患者也患有胃食管反流病（GORD）。这两种疾病似乎相互关联，持续气道正压通气（CPAP）治疗作为 OSA 的金标准治疗方法，可预防气道塌陷，已被证明可降低 GORD。由于下颌前伸装置（OSA 的二线治疗方法）对 GORD 的影响尚未得到研究，因此需要进行一项可行性研究，然后再进行确定性试验。
这将是一项单中心、单盲、三级保健、多学科、平行随机对照研究。睡眠科就诊的潜在 OSA 患者将使用经过验证的问卷进行 GORD 的预筛查，获得同意并邀请他们接受同时进行的家庭睡眠和食管 pH 监测。确诊为 OSA 和 GORD 的患者（n=44）将随机分配接受 CPAP（n=22）或 MAD 治疗（n=22）。在成功滴定和 3 周定制期后，参与者将在佩戴设备的情况下重复同时进行睡眠和食管 pH 监测。将调查招募患者的筛查数量、脱落率、患者对研究方案的反馈、干预措施的成本以及为确定研究设计提供信息的临床信息。
诺丁汉 2 研究伦理委员会已批准了健康研究管理局的批准，注册号为 22/EM/0157，该试验已在 ISRCTN 注册（https://doi.org/10.1186/ISRCTN16013232）。关于在进行家庭睡眠研究的同时进行 24 小时 pH 食管监测的可行性的明确发现将通过临床和研究网络传播，为同时管理这两种疾病提供有价值的见解。
ISRCTN 注册号：16013232。
