Abstract：
OBJECTIVE: Continuous positive airway pressure (CPAP) is the primary therapy for obstructive sleep apnea (OSA); however the effectiveness of CPAP remains suboptimal. We describe the Novel PhysIologiC prEdictors of Positive Airway Pressure Effectiveness (NICEPAP) study. Its purpose is to determine whether physiological traits of OSA contribute to CPAP effectiveness.
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.
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.
摘要：
目的：持续气道正压通气（CPAP）是阻塞性睡眠呼吸暂停（OSA）的主要治疗方法；然而，CPAP的有效性仍不理想。我们描述了气道正压通气有效性(NICECAP)研究的新物理指标。其目的是确定OSA的生理特征是否有助于CPAP的有效性。
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。
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。
