Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Kildegaardsvej 28, 2900, Hellerup, Denmark.
Department of Pulmonology, Herlev and Gentofte Hospital, Copenhagen, Denmark.
BMC Cardiovasc Disord. 2022 Jan 8;22(1):6. doi: 10.1186/s12872-021-02453-0.
Determining the presence of modifiable risk factors for atrial fibrillation (AF), such as sleep apnea is of clinical importance due to the potential impact targeting these risk factors can have on the progression and burden of AF. Using new digital-based technology is a promising solution to the underreporting of sleep apnea highlighted by academical societies in recent years. The aim of this study is to report the prevalence and severity of sleep apnea in patients with AF and, secondarily, assess the accuracy and feasibility of a new home-screening device for sleep apnea (NightOwl™ by Ectosense).
DAN-APNO is a cross-sectional study at the Department of Cardiology, Herlev-Gentofte Hospital recruiting patients with AF referred to anticoagulation initiation aged 18 to 90 years without known sleep apnea. At least 150 patients will be recruited and undergo medical history, clinical evaluation, several sleep-apnea questionnaires, and a sleep-recording evaluation for four nights with sleep apnea home-monitoring device NightOwl™. Additionally, the first 20 participants and participants with moderate-severe sleep apnea by screening are referred to cardio-respiratory monitoring (CRM). This clinical evaluation allows the comparison of standard evaluation method and the NightOwl™. Clinical measures include Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), pulse rate, as well as questionaries about sleep apnea assessment and the clinical feasibility of the NightOwl™ device. Main outcomes comprise analysis of the prevalence and severity of sleep apnea, and clinical and demographic predictors of moderate and severe sleep apnea. In addition, correlation analyses for accuracy measures between CRM and NightOwl™ will be conducted along with patient ease-of-use and satisfaction questionnaires.
This study is limited by selection bias; only patients with atrial fibrillation from anticoagulation clinic is asked to participate, which could limit the generalizability of our results. However, this study aims to test whether a miniaturized simple home-monitoring device for detecting sleep apnea in patients with AF potentially can evaluate sleep apnea more conveniently and easier. Trial Registration The study is registered the 18-02-2021 at clinicaltrials.gov with registration number: NCT04760002.
确定心房颤动 (AF) 等可改变的危险因素的存在，如睡眠呼吸暂停，具有重要的临床意义，因为针对这些危险因素可以对 AF 的进展和负担产生潜在影响。近年来，学术团体强调使用新的基于数字的技术是解决睡眠呼吸暂停报告不足的有前途的解决方案。本研究的目的是报告 AF 患者中睡眠呼吸暂停的患病率和严重程度，并其次评估一种新的睡眠呼吸暂停家庭筛查设备（Ectosense 的 NightOwl™）的准确性和可行性。
DAN-APNO 是一项在 Herlev-Gentofte 医院心脏病科进行的横断面研究，招募年龄在 18 至 90 岁、无已知睡眠呼吸暂停的 AF 患者，以开始抗凝治疗。将招募至少 150 名患者，并进行病史、临床评估、多项睡眠呼吸暂停问卷以及使用睡眠呼吸暂停家庭监测设备 NightOwl™进行四晚睡眠记录评估。此外，前 20 名参与者和通过筛查有中重度睡眠呼吸暂停的参与者被转介进行心肺监测 (CRM)。这种临床评估允许比较标准评估方法和 NightOwl™。临床测量包括呼吸暂停低通气指数 (AHI)、氧减饱和度指数 (ODI)、脉搏率以及睡眠呼吸暂停评估和 NightOwl™设备临床可行性的问卷。主要结局包括分析睡眠呼吸暂停的患病率和严重程度，以及中重度睡眠呼吸暂停的临床和人口统计学预测因素。此外，还将进行 CRM 和 NightOwl™之间准确性测量的相关分析，以及患者易用性和满意度问卷。
本研究受到选择偏倚的限制；仅要求抗凝诊所的 AF 患者参与，这可能限制了我们研究结果的普遍性。然而，本研究旨在测试一种用于检测 AF 患者睡眠呼吸暂停的小型化简单家庭监测设备是否可以更方便、更容易地评估睡眠呼吸暂停。试验注册：该研究于 2021 年 2 月 18 日在 clinicaltrials.gov 注册，注册号：NCT04760002。
