California Center for Sleep Disorders, Alameda, California.
Endpoint, LLC, Bainbridge Island, Washington.
J Clin Sleep Med. 2017 Aug 15;13(8):1009-1012. doi: 10.5664/jcsm.6710.
To determine if the application of continuous negative external pressure (cNEP) is effective and safe in individuals with obstructive sleep apnea (OSA) during an overnight in-laboratory sleep study.
A prospective, open-label pilot study in subjects with documented OSA recruited from the patient population at one sleep clinic. The intervention was application and titration of cNEP during overnight polysomnography.
Of the 15 subjects studied (mean apnea-hypopnea index [AHI] at baseline, 43.9 events/h), 13 (87%) were responders to cNEP: 9 had an excellent response (AHI < 5 events/h) and 4 had a partial response (AHI < 50% baseline and < 15 events/h). Three minor, self-limited adverse events occurred, which appeared related to contact pressure of the cNEP device on the skin.
In this pilot study, cNEP appears to be safe and effective during short-term use in subjects with OSA. Further studies are warranted.
在睡眠实验室进行的一整晚睡眠研究中，确定持续负压（cNEP）在阻塞性睡眠呼吸暂停（OSA）患者中的应用是否有效且安全。
一项前瞻性、开放标签的初步研究，在一个睡眠诊所的患者人群中招募了有明确 OSA 病史的受试者。干预措施是在整夜多导睡眠图监测期间应用和滴定 cNEP。
在 15 名研究对象中（基线时的平均呼吸暂停低通气指数 [AHI]，43.9 次/小时），13 名（87%）对 cNEP 有反应：9 名有极好的反应（AHI < 5 次/小时），4 名有部分反应（AHI < 50%基线和 < 15 次/小时）。出现了 3 起轻微的、自限性不良事件，这些事件似乎与 cNEP 设备对皮肤的接触压力有关。
在这项初步研究中，cNEP 在 OSA 患者的短期使用中似乎是安全且有效的。需要进一步的研究。
