Hung Tzu-Chun, Liu Tien-Jen, Hsieh Wen-Yeh, Chen Bo-Nien, Su Wen-Ko, Sun Kuang-Hui, Guilleminault Christian
Department of Biotechnology and Laboratory Science in Medicine, National Yang-Ming University, Taipei, Taiwan.
Department of Otolaryngology Head & Neck Surgery, MacKay Memorial Hospital, Taipei Branch, Taipei, Taiwan.
Sleep Breath. 2019 Sep;23(3):849-856. doi: 10.1007/s11325-018-01778-z. Epub 2019 Jan 28.
Patients with obstructive sleep apnea syndrome (OSAS) have difficulties in compliance with continuous positive airway pressure (CPAP) and the treatment outcome is heterogeneous. We proposed a proof-of-concept study of a novel intermittent negative air pressure (iNAP®) device for physicians to apply on patients who have failed or refused to use CPAP.
The iNAP® device retains the tongue and the soft palate in a forward position to decrease airway obstruction. A full nightly usage with the device was evaluated with polysomnography. Subgrouping by baseline apnea-hypopnea index (AHI) and body mass index (BMI) with different treatment response criteria was applied to characterize the responder group of this novel device.
Thirty-five patients were enrolled: age 41.9 ± 12.2 years (mean ± standard deviation), BMI 26.6 ± 4.3 kg/m, AHI 41.4 ± 24.3 events/h, and oxygen desaturation index (ODI) 40.9 ± 24.4 events/h at baseline. AHI and ODI were significantly decreased (p < 0.001) by the device. Patients with moderate OSAS, with baseline AHI between 15 to 30 events/h, achieved 64% response rate; and non-obese patients, with BMI below 25 kg/m, achieved 57% response rate, with response rate defined as 50% reduction in AHI from baseline and treated AHI lower than 20. There were minimal side effects reported.
In a proof-of-concept study, the device attained response to treatment as defined, in more than half of the moderate and non-obese OSAS patients, with minimal side effects.
阻塞性睡眠呼吸暂停综合征（OSAS）患者在持续气道正压通气（CPAP）治疗中依从性较差，且治疗效果存在异质性。我们开展了一项关于新型间歇性负压（iNAP®）设备的概念验证研究，供医生应用于CPAP治疗失败或拒绝使用CPAP的患者。
iNAP®设备可使舌头和软腭保持在向前的位置，以减少气道阻塞。通过多导睡眠图评估患者每晚使用该设备的情况。根据基线呼吸暂停低通气指数（AHI）和体重指数（BMI）进行亚组划分，并采用不同的治疗反应标准来确定该新型设备的反应者组。
共纳入35例患者，基线时年龄为41.9±12.2岁（均值±标准差），BMI为26.6±4.3kg/m²，AHI为41.4±24.3次/小时，氧饱和度下降指数（ODI）为40.9±24.4次/小时。该设备使AHI和ODI显著降低（p<0.001）。中度OSAS患者（基线AHI在15至30次/小时之间）的反应率为64%；非肥胖患者（BMI低于25kg/m²）的反应率为57%，反应率定义为AHI较基线降低50%且治疗后的AHI低于20。报告的副作用极少。
在一项概念验证研究中，该设备在超过半数的中度和非肥胖OSAS患者中达到了规定的治疗反应，且副作用极小。
