Division of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL 32610, USA.
Sleep. 2011 Apr 1;34(4):479-85. doi: 10.1093/sleep/34.4.479.
Investigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).
A prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.
19 sites including both academic and private sleep disorder centers
Obstructive sleep apnea with a pre-study AHI ≥10/hour
Treatment with a nasal EPAP device (N=127) or similar appearing sham device (N=123) for 3 months. Polysomnography (PSG) was performed on 2 non-consecutive nights (random order: device-on, device-off) at week 1 and after 3 months of treatment. Analysis of an intention to treat group (ITT) (patients completing week 1 PSGs) (EPAP N=119, sham N=110) was performed.
At week 1, the median AHI value (device-on versus device-off) was significantly lower with EPAP (5.0 versus 13.8 events/h, P<0.0001) but not sham (11.6 versus 11.1 events/h, P=NS); the decrease in the AHI (median) was greater (-52.7% vs. -7.3%, P<0.0001) for the ITT group. At month 3, the percentage decrease in the AHI was 42.7% (EPAP) and 10.1% (sham), P<0.0001. Over 3 months of EPAP treatment the Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P<0.0001), and the median percentage of reported nights used (entire night) was 88.2%.
The nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence.
ClinicalTrials.gov. Trial name: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO). URL: http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1.
NCT00772044.
研究一种新型鼻内呼气正压通气（EPAP）装置治疗阻塞性睡眠呼吸暂停（OSA）的疗效。
前瞻性、多中心、假对照、平行组、随机、双盲临床试验。
19 个地点，包括学术和私人睡眠障碍中心。
研究前 AHI≥10/小时的阻塞性睡眠呼吸暂停患者。
接受鼻 EPAP 装置（N=127）或类似外观的假装置（N=123）治疗 3 个月。在第 1 周和治疗 3 个月后，连续 2 晚（随机顺序：装置开启、装置关闭）进行多导睡眠图（PSG）检查。对完成第 1 周 PSG 的意向治疗组（ITT）（患者）（EPAP N=119，sham N=110）进行分析。
第 1 周，EPAP 组的中位 AHI 值（装置开启与装置关闭时）明显降低（5.0 与 13.8 事件/小时，P<0.0001），但 sham 组无显著差异（11.6 与 11.1 事件/小时，P=NS）；ITT 组 AHI 的降低幅度更大（-52.7%比-7.3%，P<0.0001）。治疗 3 个月后，AHI 的百分比降低率为 42.7%（EPAP）和 10.1%（sham），P<0.0001。在 EPAP 治疗 3 个月期间，Epworth 嗜睡量表评分降低（9.9±4.7 至 7.2±4.2，P<0.0001），报告使用整夜的中位数百分比为 88.2%。
与 sham 治疗相比，在轻至重度 OSA 患者中，新型鼻 EPAP 装置能显著降低 AHI，并改善主观白天嗜睡，且依从性极好。
ClinicalTrials.gov。试验名称：Provent 与 sham 设备治疗阻塞性睡眠呼吸暂停（AERO）的随机研究。网址：http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1。注册号：NCT00772044。
