METHODS: NICEPAP (NCT05067088) is a prospective, observational cohort study conducted at an academic sleep center. Adults newly diagnosed with OSA (n = 267) are assessed for OSA traits of loop gain, arousal threshold, pharyngeal collapsibility, and muscle compensation from baseline polysomnography. We perform a comprehensive assessment of covariates relevant to CPAP adherence, efficacy, and patient-centered outcomes. Participants are followed for 12 months. Primary outcomes include (1) CPAP adherence (hours/night), (2) CPAP efficacy (apneas-hypopneas/hour), and (3) quality of life at six months measured by objective CPAP data and Functional Outcomes of Sleep Questionnaire. Secondary outcomes include sleep quality, sleepiness, insomnia, and neurocognitive function.
RESULTS: Data on covariates, including demographics, sleep symptoms, medical history, medications, sleep quality, OSA and treatment self-efficacy, decisional balance, and socio-economic and social and partner support, are collected using validated instruments. The analysis for primary outcomes includes a generalized linear mixed model for an outcome (e.g., CPAP adherence) with OSA traits as exposures followed by the addition of relevant covariates.
CONCLUSIONS: The findings of the NICEPAP study will inform research aimed to enhance CPAP effectiveness. Understanding the role of physiological OSA traits in CPAP effectiveness is a crucial step toward a precision medicine approach to OSA.
方法:NICPCAP(NCT05067088)是一个有前景的,在学术睡眠中心进行的观察性队列研究。评估新诊断为OSA的成年人(n=267)的OSA环增益特征,唤醒阈值,咽部可折叠性,和基线多导睡眠图的肌肉补偿。我们对与CPAP依从性相关的协变量进行了全面评估,功效,和以患者为中心的结果。参与者随访12个月。主要结果包括(1)CPAP依从性(小时/夜),(2)CPAP疗效(呼吸暂停-呼吸不足/小时),(3)通过客观的CPAP数据和睡眠问卷的功能结果测量的六个月的生活质量。次要结果包括睡眠质量,困倦,失眠,和神经认知功能。
结果:协变量数据,包括人口统计,睡眠症状,病史,药物,睡眠质量,OSA和治疗自我效能感,决策平衡,以及社会经济、社会和伙伴支持,使用经过验证的仪器收集。主要结果的分析包括结果的广义线性混合模型(例如,CPAP依从性)以OSA性状作为暴露,然后添加相关协变量。
结论:NICPCAP研究结果将为旨在提高CPAP有效性的研究提供信息。了解生理OSA特征在CPAP有效性中的作用是迈向OSA精准医学方法的关键一步。