Clinical impact of customised positive airway pressure (PAP) therapy interfaces (3DPiPPIn): a single site randomised controlled trial.

Conventional interfaces do not consider facial geometries, often resulting in poor fit and ineffective therapy.

传统的接口没有考虑面部几何形状，通常会导致贴合不良和治疗效果不佳。

Three-dimensional (3D) printing of customised interfaces may improve comfort and outcomes.

定制化界面的三维（3D）打印可能会提高舒适度和治疗结果。

Background

To evaluate the clinical impact of customised versus conventional oronasal interfaces in adults with obstrcutive sleep apnoea (OSA).

评估定制化与传统口鼻界面在成人阻塞性睡眠呼吸暂停（OSA）患者中的临床影响。

The primary outcome was residual Apnoea Hypopnea Index (AHI) at 6 months; secondary outcomes included interface leak, therapy concordance and patient reported symptoms.

主要结果是6个月时的残余呼吸暂停低通气指数（AHI）；次要结果包括接口泄漏、治疗一致性以及患者报告的症状。

Methods

A randomised controlled trialwith 160 adults naïve to PAP therapy and diagnosed with SDB (AHI ≥15 events/hour).

一项涉及160名对PAP治疗无经验且被诊断为睡眠呼吸暂停低通气综合征（AHI ≥15次/小时）的成人随机对照试验。

Randomisation was minimised by age and ethnicity.

随机化过程通过年龄和种族进行最小化。

Structured light facial scans (POP2, Revopoint, China) were used to produce 3D printed moulds (Fuse 30+, Formlabs, Massachusetts, USA) for silicone injected oronasal customised interface cushions.AHI was compared using quantile regression to account for the skewed distribution of the AHI data.

使用结构光面部扫描（POP2，Revopoint，中国）制作用于硅胶注射或口腔定制界面垫的3D打印模具（Fuse 30+，Fomlabs，马萨诸塞州，美国）。使用分位数回归比较AHI，以考虑AHI数据的偏斜分布。

Secondary outcomes were compared using logistic, quantile and linear regressions.

次要结果使用逻辑回归、分位数回归和线性回归进行比较。

Results

160 participants were recruited (intervention: 82, control: 78).

共招募了160名参与者（干预组：82人，对照组：78人）。

Customised interfaces were associated with a 1.5 (events/hour) increase in AHI (p=0.059), higher interface leak (difference in medians 30.0 L/min, 95% CI 7.36 to 40.14, p<0.0001) and lower compliance (difference in compliance 0.78, 95% CI 0.05 to 1.54, p=0.04) at 6 months.

定制化接口与AHI增加1.5次/小时（p=0.059）、更高的接口泄漏（中位数差异30.0 L/min，95%置信区间7.36至40.14，p<0.0001）以及6个月时较低的依从性（依从性差异0.78，95%置信区间0.05至1.54，p=0.04）相关。

Conclusions

This trial did not demonstrate customised oronasal interfaces were superior to conventional interfaces.

该试验未能证明定制化口鼻接口优于传统接口。

Future research should focus on addressing design and manufacturing limitations before any potential advantages can be evaluated.

未来的研究应集中在解决设计和制造限制上，然后才能评估任何潜在的优势。

trial_registration_number

ISRCTN74082423.

ISRCTN74082423。