IDESP, INSERM, PreMEdical INRIA, CHU Montpellier, Montpellier University, Montpellier, France.
Groupe Adène, Montpellier, France.
Respir Res. 2024 Sep 6;25(1):331. doi: 10.1186/s12931-024-02965-1.
Over the past three decades, our understanding of sleep apnea in women has advanced, revealing disparities in pathophysiology, diagnosis, and treatment compared to men. However, no real-life study to date has explored the relationship between mask-related side effects (MRSEs) and gender in the context of long-term CPAP.
The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks, no gender specific mask series). MRSE were assessed by the patient using visual analog scales (VAS). CPAP-non-adherence was defined as a mean CPAP-usage of less than 4 h per day. The primary objective of this ancillary study was to investigate the impact of gender on the prevalence of MRSEs reported by the patient. Secondary analyses assessed the impact of MRSEs on CPAP-usage and CPAP-non-adherence depending on the gender.
A total of 1484 patients treated for a median duration of 4.4 years (IQ: 2.0-9.7) were included in the cohort, with women accounting for 27.8%. The prevalence of patient-reported mask injury, defined as a VAS score ≥ 5 (p = 0.021), was higher in women than in men (9.6% versus 5.3%). For nasal pillow masks, the median MRSE VAS score for dry mouth was higher in women (p = 0.039). For oronasal masks, the median MRSE VAS score for runny nose was higher in men (p = 0.039). Multivariable regression analyses revealed that, for both women and men, dry mouth was independently and negatively associated with CPAP-usage, and positively associated with CPAP-non-adherence.
In real-life patients treated with long-term CPAP, there are gender differences in patient reported MRSEs. In the context of personalized medicine, these results suggest that the design of future masks should consider these gender differences if masks specifically for women are developed. However, only dry mouth, a side effect not related to mask design, impacts CPAP-usage and non-adherence.
INTERFACEVENT IS REGISTERED WITH CLINICALTRIALS.GOV (NCT03013283).FIRST REGISTRATION DATE IS 2016-12-23.
在过去的三十年中,我们对女性睡眠呼吸暂停的认识有所提高,揭示了其在病理生理学、诊断和治疗方面与男性的差异。然而,迄今为止,尚无真实研究探讨长期 CPAP 中与性别相关的面罩相关副作用 (MRSE)。
InterfaceVent-CPAP 研究是一项前瞻性真实生活横断面研究,在接受至少 3 个月 CPAP 治疗的呼吸暂停成年患者中进行,且患者可自由选择面罩(34 种不同的面罩,没有专门针对性别的面罩系列)。MRSE 由患者使用视觉模拟量表 (VAS) 进行评估。CPAP 不依从定义为平均 CPAP 使用时间每天不足 4 小时。该辅助研究的主要目的是调查性别对患者报告的 MRSE 发生率的影响。次要分析根据性别评估 MRSE 对 CPAP 使用和 CPAP 不依从的影响。
共有 1484 名患者接受了中位数为 4.4 年(IQR:2.0-9.7)的治疗,其中女性占 27.8%。与男性相比,女性患者报告的面罩损伤(VAS 评分≥5)的患病率更高(p=0.021)(9.6%与 5.3%)。对于鼻枕面罩,女性口干的中位 MRSE VAS 评分更高(p=0.039)。对于口鼻面罩,男性鼻塞的中位 MRSE VAS 评分更高(p=0.039)。多变量回归分析显示,无论女性还是男性,口干均与 CPAP 使用呈独立且负相关,与 CPAP 不依从呈正相关。
在接受长期 CPAP 治疗的真实生活患者中,患者报告的 MRSE 存在性别差异。在个性化医疗的背景下,如果开发专门针对女性的面罩,这些结果表明未来面罩的设计应考虑到这些性别差异。但是,只有与面罩设计无关的副作用口干会影响 CPAP 使用和不依从。
INTERFACEVENT 在 CLINICALTRIALS.GOV 注册(NCT03013283)。首次注册日期为 2016 年 12 月 23 日。