Sharma S, Wali S, Pouliot Z, Peters M, Neufeld H, Kryger M
Section of Respiratory Medicine, University of Manitoba, Winnipeg, Canada.
Sleep. 1996 Jul;19(6):497-501. doi: 10.1093/sleep/19.6.497.
Conventional manually adjusted continuous positive airway pressure (CPAP) is an effective therapy for sleep-disordered breathing. We prospectively investigated the efficacy of a self-titrating nasal CPAP system in the acute treatment of obstructive sleep apnea (OSA) syndrome. Twenty patients with moderately severe OSA [apnea hypopnea index (AHI) > 15/hour] were enrolled in a randomized, controlled, prospective clinical trial. An initial diagnostic sleep study was performed, followed by randomization to a manually adjusted CPAP titration on one night and self titrating CPAP on the other night. On the conventional CPAP night, the CPAP was manually adjusted until abolition of all apneas and electroencephalographic (EEG) arousals, whereas the self-titrating CPAP was set in automatic mode at lights out. The self-titrating CPAP system utilized an algorithm based on airway vibration patterns to detect airway stability. The AHI decreased from 50.8 +/- 28.8/hour [mean +/- standard deviation (SD)] at baseline to 3.8 +/- 3.1/hour (p < 0.005) during manually adjusted and 6.1 +/- 5.3/hour (p < 0.005) during self-titrating CPAP. The arousal index (Ar-I) decreased from 34.1 +/- 23.1/hour (baseline) to 11.2 +/- 5.0/hour on manual adjustment (p < 0.005) and 11.3 +/- 0.3/hour on self titration (p < 0.005), whereas total sleep time was unchanged. No significant differences in any measure of oxygenation or sleep architecture were observed between the manually adjusted and self-titrating CPAP nights except that the lowest arterial oxygen saturation (SaO2) was higher with manual titration (84.4 +/- 4.2% vs. 79.9 +/- 9.7%, p < 0.05). The maximum pressure required for abolition of apneas and arousals was significantly lower (p < 0.05) during the self-titrating study (10.1 +/- 3.8 cmH2O) as compared to manually adjusted CPAP (12.3 +/- 3.9 cmH2O). Failure to increase pressure and failure to maintain minimum pressure occurred in 7 of the 20 subjects during the self-titrating study. This required manual resetting of the system in five subjects, but the system self-corrected in two subjects. An unsupervised study would have resulted in undertreatment of OSA. Based on a single-night laboratory study, self-titrating CPAP was well tolerated and improved OSA and sleep architecture comparable to manually adjusted CPAP. The future modifications of this prototype will require further research to assess its efficacy and safety in the laboratory and home environments before its recommendation for general long-term use.
传统的手动调节持续气道正压通气(CPAP)是治疗睡眠呼吸紊乱的有效方法。我们前瞻性地研究了自动调压鼻CPAP系统在急性治疗阻塞性睡眠呼吸暂停(OSA)综合征中的疗效。20例中度至重度OSA患者[呼吸暂停低通气指数(AHI)>15次/小时]被纳入一项随机、对照、前瞻性临床试验。首先进行初步诊断性睡眠研究,然后随机分为在一个晚上进行手动调节CPAP滴定,另一个晚上进行自动调压CPAP滴定。在传统CPAP滴定的晚上,手动调节CPAP直到所有呼吸暂停和脑电图(EEG)觉醒消失,而自动调压CPAP在熄灯时设置为自动模式。自动调压CPAP系统利用基于气道振动模式的算法来检测气道稳定性。AHI从基线时的50.8±28.8次/小时[平均值±标准差(SD)]在手动调节CPAP期间降至3.8±3.1次/小时(p<0.005),在自动调压CPAP期间降至6.1±5.3次/小时(p<0.005)。觉醒指数(Ar-I)从34.1±23.1次/小时(基线)在手动调节时降至11.2±5.0次/小时(p<0.005),在自动调压时降至11.3±0.3次/小时(p<0.005),而总睡眠时间不变。在手动调节CPAP和自动调压CPAP滴定的晚上,除了手动滴定的最低动脉血氧饱和度(SaO2)更高(84.4±4.2%对79.9±9.7%,p<0.05)外,在任何氧合或睡眠结构指标上均未观察到显著差异。与手动调节CPAP(12.3±3.9 cmH2O)相比,在自动调压研究期间,消除呼吸暂停和觉醒所需的最大压力显著更低(p<0.05)(10.1±3.8 cmH2O)。在自动调压研究期间,20名受试者中有7名出现压力未增加和未能维持最低压力的情况。这需要对5名受试者手动重置系统,但有2名受试者系统自行校正。一项无监督的研究可能会导致OSA治疗不足。基于单晚实验室研究,自动调压CPAP耐受性良好,在改善OSA和睡眠结构方面与手动调节CPAP相当。在推荐该原型机长期普遍使用之前,其未来的改进需要进一步研究以评估其在实验室和家庭环境中的疗效和安全性。