Sleep Medicine Associates of Texas, Dallas, TX, USA.
J Clin Sleep Med. 2009 Dec 15;5(6):532-7.
Evaluate the efficacy of a novel device placed in the nares that imposes an expiratory resistance for the treatment of obstructive sleep apnea (OSA) and evaluate adherence to the device over a 30-day in-home trial period.
One diagnostic and 3 treatment polysomnograms were administered in a Latin-square design to identify the optimal expiratory resistance to be used during the 30-day in-home trial. Subjects had repeat polysomnography with the prescribed device at the end of the 30-day trial.
Multicenter study.
Participants (N=34; age 27 to 67) with a baseline apnea-hypopnea index (AHI) > or =5.
The AHI was reduced from 24.5 _ 23.6 (mean +/- SD) to an average of 13.5 +/- 18.7 (p < 0.001) across initial treatment nights. The AHI was 15.5 +/-+/- 18.9 (p = 0.001) for the prescribed device at the end of the 30-day trial. Of 24 subjects with an AHI > 10 at baseline, 13 achieved an AHI < 10 on the initial treatment nights; 10 had a similar response on the final treatment night. Percent of the night snoring decreased from 27.5 +/- 23.2 to 11.6 +/- 13.7 (p < 0.001) on initial treatment nights and 14.6 +/- 20.6 (p = 0.013) at the end of the trial; Epworth Sleepiness scores decreased from 8.7 +/- 4.0 at baseline to 6.9 +/- 4.4 (p < 0.001) at the end of the trial; the Pittsburgh Sleep Quality Index improved from 7.4 +/- 3.3 to 6.5 +/- 3.6 (p = 0.042). Mean oxygen saturation increased from 94.8 +/- 2.0 to 95.2 +/- 1.9 (p = 0.023) on initial treatment nights and 95.3 +/- 1.9 (p = 0.003) at the end of the trial. Sleep architecture was not affected. Participants reported using the device all night long for 94% of nights during the in-home trial.
Treatment with this novel device was well tolerated and accepted by the participants. An overall reduction in AHI was documented; however, therapeutic response was variable among the participants. Further research is required to identify the ideal candidates for this new therapeutic option in the management of OSA.
评估一种新型鼻塞设备的疗效，该设备在呼气时产生阻力，以治疗阻塞性睡眠呼吸暂停（OSA），并评估在 30 天家庭试用期间对设备的依从性。
采用拉丁方设计进行 1 项诊断性和 3 项治疗性多导睡眠图检查，以确定在 30 天家庭试用期间使用的最佳呼气阻力。在 30 天试验结束时，受试者使用规定的设备重复进行多导睡眠图检查。
多中心研究。
年龄 27 至 67 岁，基线时呼吸暂停低通气指数（AHI）≥ 5 的参与者。
初始治疗夜 AHI 从 24.5±23.6（均值±标准差）降至平均 13.5±18.7（p＜0.001）。在 30 天试验结束时，规定设备的 AHI 为 15.5±18.9（p=0.001）。在基线时 AHI＞10 的 24 名受试者中，13 名在初始治疗夜 AHI＜10；10 名在最后一次治疗夜有类似的反应。夜间打鼾的百分比从初始治疗夜的 27.5±23.2%降至 11.6±13.7%（p＜0.001），在试验结束时降至 14.6±20.6%（p=0.013）；Epworth 睡眠量表评分从基线时的 8.7±4.0 降至试验结束时的 6.9±4.4（p＜0.001）；匹兹堡睡眠质量指数从 7.4±3.3 改善至 6.5±3.6（p=0.042）。初始治疗夜平均血氧饱和度从 94.8±2.0%升至 95.2±1.9%（p=0.023），试验结束时升至 95.3±1.9%（p=0.003）。睡眠结构不受影响。参与者报告在家庭试用期间，94%的夜间整晚都在使用该设备。
该新型设备的治疗耐受性良好，参与者接受度高。AHI 总体降低，但参与者之间的治疗反应存在差异。需要进一步研究以确定这种新治疗选择在 OSA 管理中的理想适应证。
