正压通气治疗与日间过度嗜睡的剂量反应关系：HomePAP 研究。

Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study.

机构信息

Cleveland Clinic Sleep Disorders Center, Cleveland, Ohio.

MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland Ohio.

出版信息

J Clin Sleep Med. 2022 Apr 1;18(4):1027-1034. doi: 10.5664/jcsm.9792.

DOI:10.5664/jcsm.9792

PMID:34870587

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8974374/

Abstract

STUDY OBJECTIVES

The clinical benefits of positive airway pressure (PAP) therapy for obstructive sleep apnea are assumed to require adherent PAP usage, defined by the Centers for Medicare & Medicaid Services as ≥ 4 hours of use ≥ 70% of nights. However, this definition is based on early data and does not necessarily capture improvements at subthreshold adherence. We explored dose-response relationships between PAP adherence measures and excessive daytime sleepiness from the HomePAP randomized controlled trial.

METHODS

Participants aged ≥ 18 years with an apnea-hypopnea index ≥ 15 events/h and baseline sleepiness (Epworth Sleepiness Scale [ESS] ≥ 12) received PAP therapy. Data were collected at baseline, 1-month follow-up, and 3-months follow-up. Regression models and receiver operating characteristic curves evaluated PAP measures as predictors of ESS change and normalization (ESS < 10).

RESULTS

In 119 participants (aged 49.4 ± 12.6 years, 66.4% male, 72.3% White), > 50% were PAP nonadherent per Centers for Medicare & Medicaid Services criteria at 3 months. The percentage of nights with PAP use ≥ 4 hours predicted ESS change ( = .023), but not when controlling for the apnea-hypopnea index. The percentage of nights with ≥ 4 hours and average PAP use provided the best discrimination for predicting ESS normalization; each 10% increase in PAP use ≥ 4 hours increased the odds of ESS normalization by 22% ( = .007); those using PAP ≥ 4 hours had a nearly 3-fold greater odds of ESS normalization ( = .025). PAP use for at least 4 hours and on 70% of nights provided the best balance between specificity (0.50) and sensitivity (0.73).

CONCLUSIONS

Although subadherent PAP usage may still confer some benefit for patients with obstructive sleep apnea, adherence to current criteria confers the highest likelihood for ESS change and normalization.

CLINICAL TRIAL REGISTRATION

Registry: ClinicalTrials.gov; Name: Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP); URL: https://clinicaltrials.gov/ct2/show/NCT00642486; Identifier: NCT00642486.

CITATION

Pascoe M, Bena J, Andrews ND, et al. Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study. 2022;18(4):1027-1034.

摘要

研究目的

人们认为，正压通气（PAP）疗法对阻塞性睡眠呼吸暂停的临床益处需要坚持使用 PAP，这一定义由医疗保险和医疗补助服务中心（Centers for Medicare & Medicaid Services）定义为每晚使用时间≥4 小时且使用率≥70%。然而，这一定义基于早期数据，不一定能反映出亚阈值依从性的改善。我们从 HomePAP 随机对照试验中探讨了 PAP 依从性测量值与日间嗜睡之间的剂量反应关系。

方法

年龄≥18 岁、呼吸暂停低通气指数（apnea-hypopnea index，AHI）≥15 次/小时且基线嗜睡（Epworth 嗜睡量表[Epworth Sleepiness Scale，ESS]≥12）的患者接受 PAP 治疗。数据在基线、1 个月随访和 3 个月随访时收集。回归模型和受试者工作特征曲线评估了 PAP 措施作为 ESS 变化和正常化（ESS＜10）的预测因子。

结果

在 119 名参与者（年龄 49.4±12.6 岁，66.4%为男性，72.3%为白人）中，超过 50%的人在 3 个月时根据医疗保险和医疗补助服务中心的标准为 PAP 非依从者。每晚使用 PAP 时间≥4 小时的比例预测 ESS 变化（ = .023），但当控制 AHI 时则不然。每晚使用 PAP 时间≥4 小时和平均 PAP 使用时间提供了最佳的预测 ESS 正常化的区分能力；每增加 10%的 PAP 使用时间≥4 小时，ESS 正常化的可能性增加 22%（ = .007）；使用 PAP 时间≥4 小时的患者 ESS 正常化的可能性几乎增加了 3 倍（ = .025）。每晚使用 PAP 时间至少 4 小时且使用时间达到 70%提供了最佳的特异性（0.50）和敏感性（0.73）平衡。

结论

尽管亚依从性的 PAP 使用可能仍对阻塞性睡眠呼吸暂停患者有一定益处，但依从当前标准最有可能使 ESS 发生变化和正常化。

临床试验注册

ClinicalTrials.gov；名称：便携式监测用于睡眠呼吸暂停的诊断和管理（HomePAP）；网址：https://clinicaltrials.gov/ct2/show/NCT00642486；标识符：NCT00642486。

参考文献

Pascoe M, Bena J, Andrews ND, et al. Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study. 2022;18(4):1027-1034.