Wellmann Norbert, Ancusa Versavia Maria, Marc Monica Steluta, Trusculescu Ana Adriana, Pescaru Camelia Corina, Martis Flavia Gabriela, Ciortea Ioana, Crisan Alexandru Florian, Maritescu Adelina, Balica Madalina Alexandra, Fira-Mladinescu Ovidiu
Doctoral School, "Victor Babes" University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania.
Center for Research and Innovation in Personalized Medicine of Respiratory Diseases (CRIPMRD), "Victor Babes", Pneumology University Clinic, University of Medicine and Pharmacy Timisoara, Eftimie Murgu Square 2, 300041 Timisoara, Romania.
J Clin Med. 2025 Jul 29;14(15):5339. doi: 10.3390/jcm14155339.
Obstructive sleep apnea (OSA) is a highly prevalent disorder that significantly impacts quality of life and daily functioning. While continuous positive airway pressure (CPAP) therapy is effective, long-term adherence remains a challenge. This single-arm observational study aimed to evaluate clinical outcomes and adherence patterns during telemedicine-supported CPAP therapy and identify distinct phenotypic response clusters in Romanian patients with OSA. This prospective observational study included 86 adults diagnosed with OSA, treated with ResMed Auto CPAP devices at "Victor Babeș" University Hospital in Timișoara, Romania. All patients were remotely monitored via the AirView™ platform and received monthly telephone interventions to promote adherence when necessary. Clinical outcomes were assessed through objective telemonitoring data. K-means clustering and t-distributed stochastic neighbor embedding (t-SNE) were employed to explore phenotypic response patterns. During telemedicine-supported CPAP therapy, significant clinical improvements were observed. The apnea-hypopnea index (AHI) decreased from 42.0 ± 21.1 to 1.9 ± 1.3 events/hour. CPAP adherence improved from 75.5% to 90.5% over six months. Average daily usage increased from 348.4 ± 85.8 to 384.2 ± 65.2 min. However, post hoc analysis revealed significant concerns about the validity of self-reported psychological improvements. Self-esteem changes showed negligible correlation with objective clinical measures (r < 0.2, all > 0.1), with only 3.3% of variance being explained by measurable therapeutic factors (R = 0.033). Clustering analysis identified four distinct adherence and outcome profiles, yet paradoxically, patients with lower adherence showed greater self-esteem improvements, contradicting therapeutic causation. Telemedicine-supported CPAP therapy with structured monthly interventions was associated with substantial clinical improvements, including excellent AHI reduction (22-fold) and high adherence rates (+15% after 6 months). Data-driven phenotyping successfully identified distinct patient response profiles, supporting personalized management approaches. However, the single-arm design prevents definitive attribution of improvements to telemonitoring versus natural adaptation or placebo effects. Self-reported psychological outcomes showed concerning patterns suggesting predominant placebo responses rather than therapeutic benefits. While the overall findings demonstrate the potential value of structured telemonitoring for objective CPAP outcomes, controlled trials are essential to establishing true therapeutic efficacy and distinguishing intervention effects from measurement bias.
阻塞性睡眠呼吸暂停（OSA）是一种高度流行的疾病，对生活质量和日常功能有重大影响。虽然持续气道正压通气（CPAP）治疗有效，但长期依从性仍然是一个挑战。这项单臂观察性研究旨在评估远程医疗支持的CPAP治疗期间的临床结果和依从模式，并识别罗马尼亚OSA患者中不同的表型反应集群。 这项前瞻性观察性研究纳入了86名被诊断为OSA的成年人，他们在罗马尼亚蒂米什瓦拉的“维克托·巴比什”大学医院接受瑞思迈自动CPAP设备治疗。所有患者均通过AirView™平台进行远程监测，并在必要时每月接受电话干预以促进依从性。通过客观的远程监测数据评估临床结果。采用K均值聚类和t分布随机邻域嵌入（t-SNE）来探索表型反应模式。 在远程医疗支持的CPAP治疗期间，观察到显著的临床改善。呼吸暂停低通气指数（AHI）从42.0±21.1降至1.9±1.3次/小时。CPAP依从性在六个月内从75.5%提高到90.5%。平均每日使用时间从348.4±85.8分钟增加到384.2±65.2分钟。然而，事后分析显示，对自我报告的心理改善的有效性存在重大担忧。自尊变化与客观临床指标的相关性微乎其微（r<0.2，均>0.1），仅有3.3%的方差可由可测量的治疗因素解释（R=0.033）。聚类分析确定了四种不同的依从性和结果概况，但矛盾的是，依从性较低的患者自尊改善更大，这与治疗因果关系相矛盾。 结构化每月干预的远程医疗支持的CPAP治疗与显著的临床改善相关，包括出色的AHI降低（22倍）和高依从率（6个月后提高15%）。数据驱动的表型分析成功识别了不同的患者反应概况，支持个性化管理方法。然而，单臂设计无法确定改善是归因于远程监测还是自然适应或安慰剂效应。自我报告的心理结果显示出令人担忧的模式，表明主要是安慰剂反应而非治疗益处。虽然总体研究结果证明了结构化远程监测对客观CPAP结果的潜在价值，但对照试验对于确定真正的治疗效果以及区分干预效果与测量偏差至关重要。
