California Center for Sleep Disorders, San Leandro, California.
Psychiatry and Behavioral Sciences-Stanford Center for Sleep Sciences and Medicine, Redwood City, California.
J Clin Sleep Med. 2022 Jan 1;18(1):305-314. doi: 10.5664/jcsm.9680.
To assess variable negative external pressure (vNEP) therapy using a range of pressures and varying collar sizes and shapes to identify combinations that improve the efficacy and comfort of this emerging therapy for obstructive sleep apnea (OSA).
This prospective, open-label pilot study included 28 eligible patients (71% men) having documented moderate OSA (apnea-hypopnea index [AHI] 15 events/h ≤ AHI ≤ 30 events/h) at 1 sleep clinic for an overnight, in-lab sleep trial. Each participant tested at least 2 of 6 available vNEP devices during sleep periods ≥ 2 hours. During the assessment of AHI by polysomnography, negative pressures of -20 cm HO to -35 cm HO were adjusted to improve each patient's response. Participants' therapeutic preferences were assessed by a questionnaire and interviews.
Twenty (71%) of the participants responded to vNEP therapy: excellent response (AHI ≤ 5 events/h) was observed in 14 (50%); 6 (21%) achieved a partial response (AHI ≤ 50% baseline). For the 20 responders, the therapy reduced the fraction of total sleep time when peripheral oxygen saturation < 90% and improved minimum pulse oximetry oxygen saturation. Six patients experienced a minor, self-limited adverse event. Twenty-six participants (93%) stated that they would use vNEP nightly.
In this pilot study, vNEP therapy markedly improved AHI and oxygenation in most patients with moderate OSA. The majority of participants found vNEP comfortable and preferable to prevailing OSA therapies. Further development and studies of vNEP are warranted.
Registry: ClinicalTrials.gov; Name: Study of Variable Negative External Pressure (vNEP) in Reducing Respiratory Event in Individuals With OSA; URL: https://clinicaltrials.gov/ct2/show/NCT04718142; Identifier: NCT04718142.
Kram JA, Pelayo R. Variable negative external pressure-An alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: A pilot study. . 2022;18(1):305-314.
评估使用不同压力和不同领圈大小和形状的可变负外部压力（vNEP）疗法，以确定可提高这种治疗阻塞性睡眠呼吸暂停（OSA）新兴疗法的疗效和舒适度的组合。
这项前瞻性、开放性试点研究纳入了 28 名符合条件的患者（71%为男性），这些患者在 1 家睡眠诊所接受了 1 个夜间、实验室睡眠试验，均被记录为患有中度 OSA（呼吸暂停-低通气指数[AHI]15 次/小时≤AHI≤30 次/小时）。每位参与者在睡眠期至少测试了 6 种可用的 vNEP 设备中的 2 种，睡眠期至少 2 小时。在通过多导睡眠图评估 AHI 时，调整了-20cmHO 至-35cmHO 的负压力，以改善每位患者的反应。通过问卷和访谈评估参与者的治疗偏好。
20 名（71%）参与者对 vNEP 治疗有反应：14 名（50%）患者观察到极好的反应（AHI≤5 次/小时）；6 名（21%）患者实现了部分反应（AHI≤50%基线）。对于 20 名应答者，该疗法降低了总睡眠时间中血氧饱和度<90%的时间分数，并改善了最小脉搏血氧饱和度。6 名患者出现轻微、自限性不良事件。26 名参与者（93%）表示他们将每晚使用 vNEP。
在这项试点研究中，vNEP 治疗显著改善了大多数患有中度 OSA 的患者的 AHI 和氧合作用。大多数参与者发现 vNEP 舒适且优于现有 OSA 治疗方法。需要进一步开发和研究 vNEP。
注册号：ClinicalTrials.gov；名称：使用可变负外部压力（vNEP）降低 OSA 个体呼吸事件的研究；网址：https://clinicaltrials.gov/ct2/show/NCT04718142；标识符：NCT04718142。
Kram JA，Pelayo R。可变负外部压力-治疗阻塞性睡眠呼吸暂停的持续气道正压通气替代疗法：一项试点研究。 2022；18（1）：305-314。
