Study Objectives:

References for the evaluation of obstructive sleep apnea (OSA) often exceed the sleep clinic’s capacity. We aimed to assess the non-inferiority of a nurse-communicated model, compared with a traditional physician-led model, for the initial management of uncomplicated OSA in the sleep clinic.

Methods:

In this non-inferiority, open-label randomized controlled trial, patients referred to the for the evaluation of uncomplicated OSA (home sleep apnea test with respiratory event index ≥ 20 events/hour), were randomized to a nurse-communicated or a physician-led management. The primary endpoint was non-inferiority in the mean change from baseline of the Epworth Sleepiness Scale (ESS) score at 3 and 6 months, assuming a non-inferiority margin of -2.0 points. Secondary outcomes included quality of life [Quebec Sleep Questionnaire (QSQ)] and positive airway pressure (PAP) adherence.

Results:

200 participants were randomized to a nurse-communicated (n=101) or physician-led management (n=99). Overall, 48 participants were lost at follow-up (27.7% and 20.4% in the nurse-communicated and physician-led groups, respectively). Most participants were treated with PAP (78.2% and 80.6 % in the nurse-communicated and physician-led management groups, respectively). There was substantial missing data for the ESS (33% and 58% at 3- and 6- months in the nurse-communicated group and 29 and 55% in the physician-led group) and QSQ (86% and 91% at 3- and 6 months 79.6 and 85.7 in the physician-led group). The difference in mean change between groups for the ESS was -0.71 (95% CI -2.25 to 0.83) at 3 months and -0.21 (95%CI -1.85 to 1.45) at 6 months. For each domain of the QSQ at 3 and 6 months, the lower bound of the 95% CI was greater than the pre-specified non-inferiority margin. PAP adherence was similar between groups.

Conclusions:

Among patients with uncomplicated OSA, nurse-communicated management was non-inferior to physician-led management, in terms of sleepiness, quality of life, as well as PAP adherence at 6 months.

Clinical Trial Registration:

Registry: ClinicalTrials.gov, Title: Management of Sleep Apnea Patients by a Clinical Nurse (Supernurse), Identifier: NCT03455920, URL: https://clinicaltrials.gov/ct2/show/NCT03455920

中文翻译：

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临床护士对睡眠呼吸暂停的诊断和管理：一项非劣效性随机临床试验

 学习目标：

阻塞性睡眠呼吸暂停 (OSA) 评估的参考资料常常超出睡眠诊所的能力。我们的目的是评估护士沟通模式与传统医生主导模式相比，在睡眠诊所对简单 OSA 进行初始管理时的非劣效性。

 方法：

在这项非劣效性、开放标签随机对照试验中，转诊评估无并发症 OSA（呼吸事件指数≥20 次/小时的家庭睡眠呼吸暂停测试）的患者被随机分配给护士沟通的患者或医生。领导管理。主要终点是 3 个月和 6 个月时 Epworth 嗜睡量表 (ESS) 评分相对于基线的平均变化的非劣效性，假设非劣效界值为 -2.0 分。次要结局包括生活质量 [魁北克睡眠问卷 (QSQ)] 和气道正压通气 (PAP) 依从性。

 结果：

200 名参与者被随机分配接受护士沟通管理 (n=101) 或医生主导管理 (n=99)。总体而言，有 48 名参与者在随访中失访（护士沟通组和医生主导组分别为 27.7% 和 20.4%）。大多数参与者接受了 PAP 治疗（护士沟通管理组和医生主导管理组分别为 78.2% 和 80.6%）。 ESS（护士沟通组中 3 个月和 6 个月时为 33% 和 58%，医生主导组中为 29% 和 55%）和 QSQ（3 个月时为 86% 和 91%）存在大量缺失数据。医生主导组 6 个月时分别为 79.6 和 85.7）。 3 个月时各组间 ESS 平均变化差异为 -0.71（95% CI -2.25 至 0.83），6 个月时为 -0.21（95% CI -1.85 至 1.45）。对于 3 个月和 6 个月时 QSQ 的每个域，95% CI 的下限大于预先指定的非劣效性界限。各组之间的 PAP 依从性相似。

 结论：

在无并发症 OSA 患者中，在嗜睡、生活质量以及 6 个月时 PAP 依从性方面，护士沟通管理并不逊色于医生主导的管理。

临床试验注册：

注册处：ClinicalTrials.gov，标题：临床护士（超级护士）对睡眠呼吸暂停患者的管理，标识符：NCT03455920，URL：https://clinicaltrials.gov/ct2/show/NCT03455920