IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.
Association pour l'assistance et la réhabilitation à domicile (Apard) groupe Adène, Montpellier, France.
BMJ Open. 2021 May 10;11(5):e044499. doi: 10.1136/bmjopen-2020-044499.
To date, continuous positive airway pressure (CPAP) remains the cornerstone of obstructive sleep apnoea treatment. CPAP data describing residual sleep-disordered breathing events (ie, the CPAP-measured apnoea-hypopnoea indices (AHI-CPAP)) is difficult to interpret because it is an entirely different metric than the polysomnography (PSG) measured AHI gold standard (AHI-PSG). Moreover, manufacturer definitions for apnoea and hypopnoea are not only different from those recommended for PSG scoring, but also different between manufacturers. In the context of CPAP initiation and widespread telemedicine at home to facilitate sleep apnoea care, there is a need for concrete evidence that AHI-CPAP can be used as a surrogate for AHI-PSG.
No published systematic review and meta-analysis (SRMA) has compared the accuracy of AHI-CPAP against AHI-PSG and the primary objective of this study is therefore to do so using published data. The secondary objectives are to similarly evaluate other sleep disordered breathing indices and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, body mass index levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4% PSG desaturation criteria versus 3% PSG on accuracy. The Preferred Reporting Items for SRMA protocols statement guided study design. Randomised controlled trials and observational studies of adult patients (≥18 years old) treated by a CPAP device will be included. The CPAP intervention and PSG comparator must be performed synchronously. PSGs must be scored manually and follow the American Academy of Sleep Medicine guidelines (2007 AASM criteria or more recent). To assess the risk of bias in each study, the Quality Assessment of Diagnostic Accuracy Studies 2 tool will be used.
This protocol received ethics committee approval on 16 July 2020 (IRB_MTP_2020_07_2020000404) and results will be disseminated via peer-reviewed publications.
PROSPERO/TRIAL REGISTRATION NUMBERS: CRD42020159914/NCT04526366; Pre-results.
迄今为止，持续气道正压通气（CPAP）仍然是治疗阻塞性睡眠呼吸暂停的基石。描述残留睡眠呼吸障碍事件的 CPAP 数据（即 CPAP 测量的呼吸暂停低通气指数（AHI-CPAP））很难解释，因为它与多导睡眠图（PSG）测量的金标准 AHI（AHI-PSG）完全不同。此外，制造商对呼吸暂停和低通气的定义不仅与 PSG 评分推荐的定义不同，而且在制造商之间也不同。在 CPAP 起始和广泛的家庭远程医疗以促进睡眠呼吸暂停护理的背景下，需要有具体的证据表明 AHI-CPAP 可以作为 AHI-PSG 的替代指标。
尚无已发表的系统评价和荟萃分析（SRMA）比较过 AHI-CPAP 与 AHI-PSG 的准确性，因此本研究的主要目的是使用已发表的数据进行比较。次要目标是类似地评估其他睡眠呼吸障碍指数，并进行亚组分析，重点关注中枢性呼吸暂停患者的纳入/排除、体重指数水平、CPAP 设备品牌、压力滴定模式、使用预定和固定压力水平或不使用、以及 4% PSG 脱氧标准与 3% PSG 对准确性的影响。首选报告项目的 SRMA 方案声明指导研究设计。将纳入接受 CPAP 设备治疗的成年患者（≥18 岁）的随机对照试验和观察性研究。CPAP 干预和 PSG 比较必须同步进行。PSG 必须手动评分，并遵循美国睡眠医学学会指南（2007 年 AASM 标准或更新标准）。为了评估每项研究的偏倚风险，将使用诊断准确性研究 2 工具进行质量评估。
本方案于 2020 年 7 月 16 日获得伦理委员会的批准（IRB_MTP_2020_07_2020000404），结果将通过同行评议的出版物传播。
PROSPERO/Trial 注册号：CRD42020159914/NCT04526366；预结果。
