Marshall Nathaniel S, Neill Alister M, Campbell Angela J
Sleep/Wake Research Centre, Massey University, Wellington, New Zealand.
Sleep Breath. 2008 Nov;12(4):393-6. doi: 10.1007/s11325-008-0189-3. Epub 2008 May 31.
Obstructive sleep apnea (OSA) is often treated with continuous positive airway pressure (CPAP) but the effectiveness of treatment is probably limited by poor compliance. CPAP manufacturers are thus attempting to devise more comfortable PAP devices in an effort to improve compliance. An example of such a novel device is Flexible expiratory-modulated PAP (C-Flex mode Respironics REMstar Pro, Murraysville, PA, USA).
We aimed to compare compliance between C-Flex and standard CPAP in patients with severe OSA in a randomised controlled trial. Nineteen patients with severe OSA (mean +/- SD Apnea Hypopnea Index = 78 +/- 33/h, Epworth 14 +/- 4, PAP 8-17 cm H2O, BMI = 39 +/- 10 kg/m2) and aged 20-63 years were randomly assigned to 4 weeks of either C-Flex (setting II, n = 9) or CPAP (n = 10).
Patients treated with C-Flex exhibited a trend toward higher compliance with their PAP devices compared to patients treated with standard CPAP (4.7 +/- 2.9 vs. 3.0 +/- 2.1 h/night, p = 0.15, effect size = 0.68). Paradoxically, improvements in subjective sleepiness (Epworth Sleepiness Scale) were greater in those who received CPAP than C-Flex (8.1 + 4.9 vs. 2.1 + 4.0 points, p = 0.014, effect size = 1.46). Improvements in objective wakefulness (Modified Maintenance of Wakefulness Test) and simple reaction times (Psychomotor Vigilance Task) were not significantly different between treatments. This randomised trial provides some evidence that C-Flex might increase initial treatment compliance, compared to CPAP, in patients with severe OSA. However, this trend toward greater compliance was not associated with better short-term treatment outcomes for patients. These findings need to be confirmed in a larger, longer-term trial.
阻塞性睡眠呼吸暂停（OSA）通常采用持续气道正压通气（CPAP）治疗，但治疗效果可能因依从性差而受限。因此，CPAP制造商正试图设计出更舒适的气道正压通气设备，以提高依从性。这种新型设备的一个例子是灵活呼气调制气道正压通气（C-Flex模式，瑞思迈公司的REMstar Pro，美国宾夕法尼亚州默里斯维尔）。
我们旨在通过一项随机对照试验，比较重度OSA患者使用C-Flex和标准CPAP的依从性。19例重度OSA患者（平均±标准差呼吸暂停低通气指数=78±33次/小时，爱泼沃斯嗜睡量表评分为14±4分，气道正压通气压力为8-17厘米水柱，体重指数=39±10千克/平方米），年龄在20-63岁之间，被随机分配接受为期4周的C-Flex治疗（设置II，n=9）或CPAP治疗（n=10）。
与接受标准CPAP治疗的患者相比，接受C-Flex治疗的患者对气道正压通气设备的依从性有升高趋势（4.7±2.9小时/晚对3.0±2.1小时/晚，p=0.15，效应量=0.68）。矛盾的是，接受CPAP治疗的患者主观嗜睡程度（爱泼沃斯嗜睡量表）的改善比接受C-Flex治疗的患者更大（8.1+4.9分对2.1+4.0分，p=0.014，效应量=1.46）。两种治疗方法在客观清醒程度（改良清醒维持试验）和简单反应时间（精神运动警觉任务）方面的改善没有显著差异。这项随机试验提供了一些证据，表明与CPAP相比，C-Flex可能会提高重度OSA患者的初始治疗依从性。然而，这种更高依从性的趋势与患者更好的短期治疗结果无关。这些发现需要在更大规模、更长期的试验中得到证实。
