卡伊罗斯正压通气（KPAP）在效果上等同于持续气道正压通气（CPAP），并且在阻塞性睡眠呼吸暂停治疗中提供更高的舒适度。

Kairos positive airway pressure (KPAP) equals continuous PAP in effectiveness, and offers superior comfort for obstructive sleep apnea treatment.

作者信息

White David P, Messineo Ludovico, Thompson Evelyn, Hughes Bryan, Lannom Wilson D, Hete Bernard, Joshi Abinash, Noah William H

机构信息

Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital & Harvard Medical School, Boston, MA, USA.

出版信息

Sleep Med. 2024 Dec;124:268-275. doi: 10.1016/j.sleep.2024.09.028. Epub 2024 Sep 18.

DOI:10.1016/j.sleep.2024.09.028

PMID:39341027

Abstract

STUDY OBJECTIVES

A recent study challenged the prevailing clinical view that maintaining inspiratory positive airway pressure (IPAP) is necessary for upper airway patency, demonstrating no differences in apnea hypopnea index (AHI) between continuous PAP (CPAP) with and without a resistor to reduce IPAP. In this study, we assessed the effect of Kairos PAP (KPAP), a new algorithm which features multiple drops in IPAP, only returning to therapeutic pressure near the end expiration, on sleep apnea severity and subjective comfort.

METHODS

Two randomized clinical trials were conducted. In the Efficacy trial, the effect of KPAP vs. CPAP on AHI in PAP-treated OSA patients was examined using a split-night design, adjusting for period, sequence and fraction of supine sleep (mixed models). Unintentional leak differences between treatments were also examined. Exploratory analyses assessed the effect of KPAP vs. CPAP on key polysomnography outcomes. In the Comfort trial, we tested subjective preference for KPAP vs. CPAP at 9 and 13 cmHO in PAP-naïve OSA patients.

RESULTS

In the Efficacy trial (N = 48), KPAP reduced AHI more than CPAP (mean difference [95%CI]: -0.5 [-0.8, -0.2] events/h, P = 0.007). Unintentional leak was also reduced by over 50 % (-2.5 [-3.2, -1.7] L/min, P < 0.001). No significant change was observed in the exploratory variables assessed. In the Comfort trial (N = 150), 69 [61, 77] % and 84 [77, 89] % of participants preferred KPAP over CPAP at 9 and 13 cmHO, respectively (P < 0.001).

CONCLUSIONS

KPAP is as effective as CPAP in reducing respiratory events, but is more comfortable and potentially better tolerated.

摘要

研究目的

最近一项研究对维持吸气气道正压（IPAP）对保持上气道通畅至关重要这一普遍临床观点提出了挑战，该研究表明，在使用和不使用降低IPAP的电阻器的持续气道正压通气（CPAP）之间，呼吸暂停低通气指数（AHI）并无差异。在本研究中，我们评估了Kairos PAP（KPAP）这一新型算法对睡眠呼吸暂停严重程度和主观舒适度的影响，该算法的特点是IPAP多次下降，仅在呼气末期接近治疗压力。

方法

进行了两项随机临床试验。在疗效试验中，采用分夜设计，调整仰卧睡眠的时期、顺序和比例（混合模型），研究KPAP与CPAP对接受PAP治疗的阻塞性睡眠呼吸暂停（OSA）患者AHI的影响。还研究了不同治疗之间的无意漏气差异。探索性分析评估了KPAP与CPAP对关键多导睡眠图结果的影响。在舒适度试验中，我们测试了初治OSA患者在9和13 cmH₂O压力下对KPAP与CPAP的主观偏好。

结果

在疗效试验（N = 48）中，KPAP降低AHI的效果优于CPAP（平均差值[95%CI]：-0.5 [-0.8, -0.2]次/小时，P = 0.007）。无意漏气也减少了50%以上（-2.5 [-3.2, -1.7]升/分钟，P < 0.001）。在评估的探索性变量中未观察到显著变化。在舒适度试验（N = 150）中，分别有69 [61, 77]%和84 [77, 89]%的参与者在9和13 cmH₂O压力下更喜欢KPAP而非CPAP（P < 0.001）。