Sleep Therapy & Research Center, San Antonio, TX 78229, USA.
J Clin Sleep Med. 2012 Feb 15;8(1):43-7. doi: 10.5664/jcsm.1658.
We hypothesized that early intervention with an auto bilevel device would improve treatment adherence compared to CPAP among OSA patients with a poor initial experience with lab-based CPAP titration.
Patients with a poor initial CPAP experience were recruited for this parallel group, randomized, double-blind, controlled pilot study. After an in-lab titration, patients were randomized with either an auto-bilevel device or CPAP. Treatment adherence and functioning were assessed at 90 days.
We enrolled 51 subjects, with 47 completing the protocol. Groups were equally matched for gender, age, education, and OSA severity. There was no significant difference in the proportion of compliant subjects (≥ 4 h/night) between the auto bilevel and CPAP groups (62% vs. 54%; p = 0.624) after 90 days of use. Functional outcomes significantly improved in both groups during treatment use (p < 0.001) but did not differ between groups.
There was no statistically significant difference in adherence between the auto bilevel and CPAP groups in this study. Patients with a poor initial CPAP exposure may still achieve an acceptable long-term clinical outcome. Both groups demonstrated comparably significant improvements in functional outcomes, sleepiness, and fatigue complaints over the treatment period. CLINICAL TRIALS INFORMATION: NCT00635206 ClinicalTrials.gov
我们假设，与 CPAP 相比，在 CPAP 初始实验室滴定中体验不佳的 OSA 患者中，早期使用自动双水平设备干预将提高治疗依从性。
这项平行组、随机、双盲、对照的初步研究招募了 CPAP 初始体验不佳的患者。在实验室滴定后，患者被随机分配使用自动双水平设备或 CPAP。在 90 天时评估治疗依从性和功能。
我们共纳入了 51 名受试者，其中 47 名完成了方案。两组在性别、年龄、教育程度和 OSA 严重程度方面匹配良好。使用 90 天后，符合标准（≥4 小时/晚）的受试者比例在自动双水平组和 CPAP 组之间没有显著差异（62%对 54%；p=0.624）。在治疗期间，两组的功能结果均显著改善（p<0.001），但组间无差异。
在这项研究中，自动双水平组和 CPAP 组之间的依从性没有统计学上的显著差异。CPAP 初始暴露不佳的患者仍可能获得可接受的长期临床结果。两组在治疗期间均表现出相似的显著改善，包括功能结果、嗜睡和疲劳症状。
NCT00635206 ClinicalTrials.gov
