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Inspire装置舌下神经刺激对不耐受持续气道正压通气治疗的阻塞性睡眠呼吸暂停患者生活质量的影响。

Quality of Life Impact of Hypoglossal Nerve Stimulation with Inspire Device in Patients with Obstructive Sleep Apnea Intolerant to Continuous Positive Airway Pressure Therapy.

作者信息

Baptista Peter, Di Frisco I Madeleine, Urrestarazu Elena, Alcalde Juan, Alegre Manuel, Sanchez Isabel, O'Connor-Reina Carlos, Plaza Guillermo

机构信息

Otorhinolaryngology Department, University Clinic of Navarra, 31007 Pamplona, Spain.

Pulmonology Department, Clínica Universidad de Navarra, 31007 Pamplona, Spain.

出版信息

Life (Basel). 2022 Oct 28;12(11):1737. doi: 10.3390/life12111737.

Abstract

Patients with obstructive sleep apnea (OSA) that do not tolerate/accept continuous positive airway pressure (CPAP) are candidates for surgical alternatives. Hypoglossal nerve stimulation (HNS) through the implantation of the Inspire® device constitutes a minimally invasive operative option. The main objective of this study is to estimate, under real-world clinical practice conditions, the 3-month impact on the quality of life (IQoL) of the HNS in patients with moderate/severe OSA who do not tolerate or accept CPAP, compared to patients who did not receive HNS. As a baseline, the unadjusted EuroQol utility index was 0.764 (SD:0.190) in the intervention group (IGr) and 0.733 (SD:0.205) in the control group (CGr); three months later, the indexes were 0.935 (SD: 0.101) and 0.727 (SD:0.200), respectively. The positive impact on quality of life was estimated to be +0.177 (95% CI: 0.044−0.310; p = 0.010). All dimensions in the IGr improved compared to CGr, especially for usual activities (p < 0.001) and anxiety/depression (p > 0.001). At the end of the follow-up, there was no significant difference in the quality of life between the general Spanish population and the IGr (difference: 0.012; CI95%: −0.03 to −0.057; p = 0.0578) for the same age range; however, there was a difference concerning the CGr (difference: −0.196; CI95%: −0.257 to −0.135; p < 0.001). In conclusion, patients with moderate/severe OSA implanted with the Inspire® device showed a positive IQoL.

摘要

不耐受/不接受持续气道正压通气(CPAP)的阻塞性睡眠呼吸暂停(OSA)患者可选择手术治疗。通过植入Inspire®设备进行舌下神经刺激(HNS)是一种微创手术选择。本研究的主要目的是在真实世界的临床实践条件下,评估与未接受HNS的患者相比,HNS对不耐受或不接受CPAP的中重度OSA患者3个月生活质量(IQoL)的影响。作为基线,干预组(IGr)的未调整欧洲五维度健康量表效用指数为0.764(标准差:0.190),对照组(CGr)为0.733(标准差:0.205);三个月后,指数分别为0.935(标准差:0.101)和0.727(标准差:0.200)。对生活质量的积极影响估计为+0.177(95%置信区间:0.044 - 0.310;p = 0.010)。与CGr相比,IGr的所有维度均有所改善,尤其是日常活动(p < 0.001)和焦虑/抑郁(p > 0.001)。随访结束时,在相同年龄范围内,西班牙普通人群与IGr的生活质量无显著差异(差异:0.012;95%置信区间:-0.03至-0.057;p = 0.0578);然而,与CGr存在差异(差异:-0.196;95%置信区间:-0.257至-0.135;p < 0.001)。总之,植入Inspire®设备的中重度OSA患者显示出积极的IQoL。

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