Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing.

IF 2.1 4区医学 Q3 CLINICAL NEUROLOGY

Sleep and Breathing Pub Date : 2025-01-20 DOI:10.1007/s11325-025-03250-1

Benjamin D Fox, Murad Shihab, Abed Nassir, Dahlia Kushinsky, Ofer Barnea, Asher Tal

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引用次数: 0

Abstract

Purpose: This study aimed to validate the new DormoTech Vlab device's performance, usability, and validity as a sleep test and physiological data recorder. The novel device has been designed for patient comfort, ease of use, and home-based assessment of sleep disordered breathing and other sleep-related measurements.

Methods: Forty-seven adults (mean age = 52 years, 42% female, body mass index 29.4 kg/m²) underwent simultaneous testing with the DormoTech Vlab device and routine full polysomnography (PSG) using the Nox A1 system (K192469, Nox Medical). The sleep studies were manually and independently scored according to recommended guidelines. The primary outcome measure was the apnea-hypopnea index (AHI) and its corresponding conventional severity level (i.e., normal, mild, moderate, severe). Secondary endpoints included other standard PSG parameters.

Results: The AHI was 21.7 ± 24.2 events/h (mean ± standard deviation) using the Vlab device versus 21.5 ± 23.9 events/h for gold standard PSG Nox A1 (p = 0.7). When AHI was grouped by severity, inter-test agreement was high (Cohen's kappa = 0.97). Results between the two systems were largely similar in the secondary endpoints, with high correlation between the two systems, and statistically significant (p < 0.05) differences only in REM latency measurements. The Vlab device provides similar sleep study data to conventional gold standard PSG and clinically near-identical test interpretation in almost all cases.

Conclusion: Based on these results, the Vlab device can be considered substantially equivalent to the reference Nox A1 system in terms of usability, efficacy, and validity.

Clinical trial registration: Trial name: Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test Identification number: NCT06224972. Date of Registration: 2023-12-06.

查看原文本刊更多论文

一种基于面罩的新型设备的验证，用于监测综合睡眠参数和睡眠呼吸障碍。

目的：本研究旨在验证新的DormoTech Vlab设备作为睡眠测试和生理数据记录仪的性能、可用性和有效性。这种新型设备的设计是为了让患者感到舒适、易于使用，以及对睡眠呼吸障碍和其他与睡眠相关的测量进行家庭评估。方法：47名成年人（平均年龄52岁，42%为女性，体重指数29.4 kg/m2）同时使用DormoTech Vlab设备和Nox A1系统（K192469, Nox Medical）进行常规全多导睡眠描图（PSG）检测。睡眠研究是根据推荐的指导方针手动独立评分的。主要结局指标为呼吸暂停低通气指数（AHI）及其相应的常规严重程度（即正常、轻度、中度、重度）。次要终点包括其他标准PSG参数。结果：使用Vlab设备的AHI为21.7±24.2事件/小时（平均±标准差），而金标准PSG Nox A1的AHI为21.5±23.9事件/小时（p = 0.7）。当AHI按严重程度分组时，测试间一致性高（Cohen’s kappa = 0.97）。两种系统的次要终点结果基本相似，两种系统之间具有高度相关性，且具有统计学意义(p)。结论：基于这些结果，Vlab设备在可用性、功效和有效性方面可被认为与参考Nox A1系统基本等同。临床试验注册：试验名称：DormoTech VLAB设备作为家庭睡眠测试的可用性评估和性能评估识别号：NCT06224972。注册日期：2023-12-06。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Sleep and Breathing 医学-呼吸系统

CiteScore

5.20

自引率

4.00%

发文量

222

审稿时长

3-8 weeks

期刊介绍： The journal Sleep and Breathing aims to reflect the state of the art in the international science and practice of sleep medicine. The journal is based on the recognition that management of sleep disorders requires a multi-disciplinary approach and diverse perspectives. The initial focus of Sleep and Breathing is on timely and original studies that collect, intervene, or otherwise inform all clinicians and scientists in medicine, dentistry and oral surgery, otolaryngology, and epidemiology on the management of the upper airway during sleep. Furthermore, Sleep and Breathing endeavors to bring readers cutting edge information about all evolving aspects of common sleep disorders or disruptions, such as insomnia and shift work. The journal includes not only patient studies, but also studies that emphasize the principles of physiology and pathophysiology or illustrate potentially novel approaches to diagnosis and treatment. In addition, the journal features articles that describe patient-oriented and cost-benefit health outcomes research. Thus, with peer review by an international Editorial Board and prompt English-language publication, Sleep and Breathing provides rapid dissemination of clinical and clinically related scientific information. But it also does more: it is dedicated to making the most important developments in sleep disordered breathing easily accessible to clinicians who are treating sleep apnea by presenting well-chosen, well-written, and highly organized information that is useful for patient care.