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有限通道睡眠研究与多导睡眠图在阻塞性睡眠呼吸暂停诊断中的临床效用比较

Clinical utility of limited channel sleep studies versus polysomnography for obstructive sleep apnoea.

作者信息

van Doorn Sander, Idema Demy L, Heus Pauline, Damen Johanna Aag, Spijker René, Japenga Eva J, Reesink Herre J, Hooft Lotty

机构信息

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.

Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.

出版信息

Cochrane Database Syst Rev. 2025 May 6;5(5):CD013810. doi: 10.1002/14651858.CD013810.pub2.

Abstract

BACKGROUND

Obstructive sleep apnoea (OSA) is a common cause of sleep disturbance, characterised by the presence of repetitive upper airway obstruction during sleep. OSA is associated with sleepiness during the day, reduced quality of life and an increased risk of cardiovascular disease. OSA can be diagnosed using several different strategies. The current reference test is fully supervised polysomnography, which is expensive and time-consuming. Other diagnostic tests, referred to as limited channel sleep studies because they include fewer parameters than polysomnography, are less resource-intensive but may also have different diagnostic performances, resulting in a difference in clinical outcomes.

OBJECTIVES

To assess the clinical impact (outcome on a participant level) of a strategy where treatment follows diagnostic testing (test-treatment combination) using limited channel sleep studies compared to polysomnography in people with suspected obstructive sleep apnoea (OSA).

SEARCH METHODS

We searched two databases (CENTRAL, MEDLINE) up to 11 May 2023 using search terms related to OSA and polysomnography developed by our information specialist.

SELECTION CRITERIA

We included randomised controlled trials that compared any limited channel sleep studies with Level I fully supervised polysomnography in adults (aged 18 years and older) with suspected OSA. Our primary outcome was sleepiness, and our secondary outcomes were quality of life, all-cause mortality, cardiovascular events and correlating risk factors, continuous positive airway pressure (CPAP) usage, serious adverse events, and cost-effectiveness.

DATA COLLECTION AND ANALYSIS

Four review authors extracted data from the included trials and assessed the risk of bias. We summarised treatment effects using random-effects meta-analyses and expressed as mean difference (MD) or standardised mean difference (SMD) with corresponding 95% confidence intervals (CI) where possible. We used GRADE to assess the certainty of the evidence.

MAIN RESULTS

We included three trials with 1143 participants. One trial compared Level III sleep studies to a Level I fully supervised polysomnography, one trial compared Level IV sleep studies to Level I sleep studies, and one trial compared Level IV sleep studies versus Level III sleep studies versus Level I sleep studies. The follow-up of these trials ranged from four to six months. Level III sleep studies versus Level I sleep studies There is high-certainty evidence that Level III sleep studies result in little to no difference in sleepiness (MD 0.47, 95% CI -0.23 to 1.18; P = 0.19, I = 0%; 2 trials, 701 participants) or quality of life (SMD 0.01, 95% CI -0.14 to 0.16; P = 0.93, I = 0%; 2 trials, 701 participants) compared to Level I sleep studies. Level III sleep studies are also probably slightly more cost-effective (moderate-certainty evidence). There is low-certainty evidence that they may result in little to no difference in cardiovascular events and correlating risk factors, CPAP adherence (MD -0.18 hours per day, 95% CI -0.56 to 0.20; P = 0.36, I = 0%; 2 trials, 360 participants) or serious adverse events. Level IV sleep studies versus Level I sleep studies There is low-certainty evidence that Level IV sleep studies may not increase sleepiness compared to Level I sleep studies (MD 0.66, 95% CI -0.41 to 1.72; P = 0.23, I = 39%; 2 trials, 573 participants). Additionally, there is low-certainty evidence that they may result in little to no difference in cardiovascular events and correlating risk factors. For quality of life, CPAP adherence, serious adverse events and cost-effectiveness, the evidence is very uncertain. None of the included trials reported on all-cause mortality.

AUTHORS' CONCLUSIONS: Level III sleep studies may result in little to no difference in clinical outcomes when compared to Level 1 sleep studies in people with suspected OSA. Level IV sleep studies may not increase sleepiness and may result in little to no difference in cardiovascular events and correlating risk factors compared to Level I sleep studies; the evidence was too uncertain to make statements for other outcomes. Overall, the body of evidence was limited, therefore more trials making this comparison are necessary, as are trials with a longer follow-up duration.

摘要

背景

阻塞性睡眠呼吸暂停(OSA)是睡眠障碍的常见原因,其特征是睡眠期间反复出现上气道阻塞。OSA与白天嗜睡、生活质量下降以及心血管疾病风险增加有关。OSA可通过几种不同策略进行诊断。目前的参考测试是全程监督的多导睡眠图,该方法昂贵且耗时。其他诊断测试,因其包含的参数比多导睡眠图少,被称为有限通道睡眠研究,资源消耗较少,但诊断性能也可能不同,从而导致临床结果存在差异。

目的

评估在疑似阻塞性睡眠呼吸暂停(OSA)患者中,与多导睡眠图相比,使用有限通道睡眠研究进行诊断测试后再进行治疗(测试 - 治疗组合)的策略对临床的影响(参与者层面的结果)。

检索方法

我们使用信息专家制定的与OSA和多导睡眠图相关的检索词,检索了截至2023年5月11日的两个数据库(CENTRAL、MEDLINE)。

入选标准

我们纳入了将任何有限通道睡眠研究与I级全程监督多导睡眠图进行比较的随机对照试验,研究对象为疑似OSA的成年人(18岁及以上)。我们的主要结局是嗜睡,次要结局是生活质量、全因死亡率、心血管事件及相关危险因素、持续气道正压通气(CPAP)的使用情况、严重不良事件以及成本效益。

数据收集与分析

四位综述作者从纳入的试验中提取数据并评估偏倚风险。我们使用随机效应荟萃分析总结治疗效果,并尽可能以平均差(MD)或标准化平均差(SMD)及相应的95%置信区间(CI)表示。我们使用GRADE评估证据的确定性。

主要结果

我们纳入了三项试验,共1143名参与者。一项试验将III级睡眠研究与I级全程监督多导睡眠图进行比较,一项试验将IV级睡眠研究与I级睡眠研究进行比较,还有一项试验将IV级睡眠研究与III级睡眠研究以及I级睡眠研究进行比较。这些试验的随访时间为4至6个月。III级睡眠研究与I级睡眠研究相比 有高确定性证据表明,与I级睡眠研究相比,III级睡眠研究在嗜睡(MD 0.47,95%CI -0.23至1.18;P = 0.19,I² = 0%;2项试验,701名参与者)或生活质量(SMD 0.01,95%CI -0.14至0.16;P = 0.93,I² = 0%;2项试验,701名参与者)方面几乎没有差异。III级睡眠研究在成本效益方面可能也略高(中等确定性证据)。有低确定性证据表明,它们在心血管事件及相关危险因素、CPAP依从性(MD -0.18小时/天,95%CI -0.56至0.20;P = 0.36,I² = 0%;2项试验,360名参与者)或严重不良事件方面可能几乎没有差异。IV级睡眠研究与I级睡眠研究相比 有低确定性证据表明,与I级睡眠研究相比,IV级睡眠研究可能不会加重嗜睡(MD 0.66,95%CI -0.41至1.72;P = 0.23,I² = 39%;2项试验,573名参与者)。此外,有低确定性证据表明,它们在心血管事件及相关危险因素方面可能几乎没有差异。对于生活质量、CPAP依从性、严重不良事件和成本效益,证据非常不确定。纳入的试验均未报告全因死亡率。

作者结论

与I级睡眠研究相比,III级睡眠研究在疑似OSA患者中的临床结局可能几乎没有差异。与I级睡眠研究相比,IV级睡眠研究可能不会加重嗜睡,在心血管事件及相关危险因素方面可能几乎没有差异;证据过于不确定,无法对其他结局作出陈述。总体而言,证据有限,因此需要更多进行此比较的试验,以及随访时间更长的试验。

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