远程患者监测对阻塞性睡眠呼吸暂停患者PAP依从性及患者报告结局的影响：一项比较研究

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中文摘要

目的： 阻塞性睡眠呼吸暂停（OSA）是一种常见疾病，气道正压（PAP）是标准治疗；然而，其有效性取决于依从性。远程患者监测（RPM）可能改善PAP依从性，但证据仍然有限。
方法： 我们开展了一项前瞻性、开放标签、活性对照、随机试验，在拥有智能手机的PAP初治成人OSA患者（≥18岁）中比较RPM项目与标准治疗（SOC）。参与者按1:1随机分配至SOC（PAP治疗联合标准指导项目）或RPM（通过基于网络的应用程序监测PAP治疗并给予指导）。主要终点为Medicare定义的PAP依从性（前90天内连续30天期间，超过70%的夜晚使用时间>4小时）。次要终点包括面罩漏气升高的夜晚数、患者报告的睡眠指标和患者满意度（Likert量表），并对多重比较采用Benjamini-Hochberg校正。鉴于实用性样本量，本研究旨在估计组间差异，而非以传统把握度检验优效性。
结果： 196名参与者（每组98名）中65%为男性，年龄中位数（四分位距）为51（41-62）岁，体重指数为32（29-37）kg/m²。Medicare定义的PAP依从性在RPM组为80.6%，在SOC组为73.5%（差异7.1个百分点；p=0.308）。第90天时，RPM组面罩漏气升高的夜晚数更少（中位数11.2 vs. 14.5；未校正p=0.009；校正p=0.113），并且报告对支持及时性、指导项目和问题解决满意度最高的参与者比例更高（未校正p=0.031-0.044）。经多重比较校正后，这些差异均不再显著（所有校正p≥0.11）。
结论： 由于样本量有限，结论主要为描述性。Medicare定义的PAP依从性在RPM与SOC之间无显著差异。RPM组面罩漏气升高的夜晚数更少且满意度评分更高，但这些差异经多重比较校正后不显著，需要在把握度充分的研究中确认。
试验注册： 于2025年9月19日在https//clinicaltrials.gov/study/NCT07182617回顾性注册。

英文摘要

PURPOSE: Obstructive sleep apnea (OSA) is a common condition, and positive airway pressure (PAP) is the standard therapy; however, its effectiveness depends on adherence. Remote patient monitoring (RPM) may improve PAP adherence, but evidence remains limited.
METHODS: We conducted a prospective, open-label, active-comparator, randomized trial comparing an RPM program with standard of care (SOC) in PAP-naive adults (≥ 18 years) with OSA who owned a smartphone. Participants were randomized 1:1 to SOC (PAP therapy with a standard coaching program) or RPM (PAP therapy monitored through a web-based application with coaching). The primary endpoint was Medicare-defined PAP adherence (> 4 h of use on > 70% of nights during a consecutive 30-day period within the first 90 days). Secondary endpoints included nights with elevated mask leak, patient-reported sleep measures, and patient satisfaction (Likert scale), with Benjamini-Hochberg adjustment for multiple comparisons. Given the pragmatic sample size, the study was designed to estimate between-arm differences rather than to test superiority with conventional power.
RESULTS: The 196 participants (98 per arm) were 65% male, with a median (interquartile range) age of 51 (41-62) years and body mass index of 32 (29-37) kg/m². Medicare-defined PAP adherence was 80.6% in the RPM group and 73.5% in the SOC group (difference 7.1% points; p = 0.308). At day 90, the RPM group had fewer nights with elevated mask leak (median 11.2 vs. 14.5; unadjusted p = 0.009; adjusted p = 0.113) and a higher proportion of participants reporting the highest satisfaction with timeliness of support, the coaching program, and issue resolution (unadjusted p = 0.031-0.044). None of these differences remained significant after adjustment for multiple comparisons (all adjusted p ≥ 0.11).
CONCLUSIONS: Because of the limited sample size, conclusions are primarily descriptive. Medicare-defined PAP adherence did not differ significantly between RPM and SOC. The RPM group had fewer nights with elevated mask leak and higher satisfaction scores, but these differences were not significant after adjustment for multiple comparisons and require confirmation in an adequately powered trial.
TRIAL REGISTRATION: Retrospectively registered on 20,250,919 at https//clinicaltrials.gov/study/NCT07182617.