Pepin Jean Louis, Gagnadoux Frédéric, Foote Alison, Vicars Rachel, Ogra Bhavi, Viot-Blanc Véronique, Benmerad Meriem, D'Ortho Marie-Pia, Tamisier Renaud
Hypoxia-pathophysiology Laboratory - INSERM U1042, Grenoble Alps University Hospital, Université Grenoble Alpes, Grenoble, France.
Department of Pneumology, INSERM URM 1063, Angers University Hospital, Bretagne Loire University I, Angers, France.
BMJ Open. 2017 Oct 27;7(10):e015836. doi: 10.1136/bmjopen-2017-015836.
Obstructive sleep apnoea (OSA) is a common sleep breathing disorder affecting up to 17% of the middle-aged population. Continuous positive airway pressure (CPAP) is the primary treatment for patients with OSA, but acceptance and adherence to therapy is suboptimal in specific subgroups particularly those with insomnia or poor sleep quality (40%-80% of patients with OSA). Pressure intolerance, particularly during periods of wakefulness, inhibiting sleep onset or return to sleep, is one reason for poor CPAP adherence. AutoCPAPs continually monitor airflow changes and only increase the pressure when the upper airway requires it. Reducing the pressure during wakefulness-sleep transition and wakefulness-after-sleep-onset (WASO) may improve therapy comfort and potentially adherence without compromising therapy efficacy. We hypothesise that SensAwake, a pressure relief function that reduces CPAP pressure on the transition from sleep to wakefulness and on WASO, may improve objective sleep quality.
This is a multicentre, randomised double-blind crossover clinical trial on patients with both OSA and insomnia. Insomnia is defined as Insomnia Severity Index >15 at screening. Baseline data, including actigraphy, are collected for 1 week before randomisation (1:1) to either conventional AutoCPAP or AutoCPAP with SensAwake for 4 weeks. After an evaluation visit, patients are switched to the other treatment arm for a further 4 weeks. Allowing for 20% dropout, 48 patients are required. If applicable, repeated measures analysis of variance will be used to assess differences in WASO measured by actigraphy (primary outcome), other actigraphy measures, AutoCPAP compliance, subjective questionnaire scores (Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Short-Form 12 Health Survey) and 24 hours blood pressure (secondary outcomes).
The protocol was approved by the regional Ethics Committee (CPP Sud-Est-V, IRB N°6705) on 9 December 2015, is registered on ClincalTrials.gov (NCT02721329) and started in June 2016 with expected publication of primary outcome results in 2018.
NCT0272132; Pre-results.
阻塞性睡眠呼吸暂停（OSA）是一种常见的睡眠呼吸障碍，影响着高达17%的中年人群。持续气道正压通气（CPAP）是OSA患者的主要治疗方法，但在特定亚组中，尤其是那些患有失眠或睡眠质量差的患者（占OSA患者的40%-80%），对治疗的接受度和依从性并不理想。压力不耐受，尤其是在清醒期间，会抑制入睡或再次入睡，这是CPAP依从性差的一个原因。自动调压持续气道正压通气设备（AutoCPAP）会持续监测气流变化，仅在上呼吸道需要时才增加压力。在从睡眠到清醒的过渡期间以及睡眠开始后的清醒期（WASO）降低压力，可能会提高治疗舒适度，并有可能提高依从性，同时不影响治疗效果。我们假设，SensAwake（一种在从睡眠过渡到清醒以及在WASO期间降低CPAP压力的压力缓解功能）可能会改善客观睡眠质量。
这是一项针对同时患有OSA和失眠的患者的多中心、随机双盲交叉临床试验。失眠定义为筛查时失眠严重程度指数>15。在随机分组（1:1）为常规AutoCPAP或带有SensAwake功能的AutoCPAP之前1周收集包括活动记录仪数据在内的基线数据，治疗4周。经过一次评估访视后，患者切换到另一个治疗组再治疗4周。考虑到20%的失访率，需要48名患者。如果适用，将使用重复测量方差分析来评估通过活动记录仪测量的WASO（主要结局）、其他活动记录仪测量指标、AutoCPAP依从性、主观问卷评分（爱泼华嗜睡量表、匹兹堡睡眠质量指数、简短健康调查问卷12项版本）以及24小时血压（次要结局）的差异。
该方案于2015年12月9日获得地区伦理委员会（CPP Sud-Est-V，IRB编号6705）批准，已在ClinicalTrials.gov（NCT02721329）注册，并于2016年6月开始，预计主要结局结果将于2018年发表。
NCT0272132；预结果。
