Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- REI parameters
研究概览
简要总结
OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Age 18-80
- •Clinically assessed and suspicious for OSA
排除标准
- •Full night PAP titration study
- •On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
- •Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF < 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
- •Patients taking narcotics
- •Recent hospitalization or recent surgery in the past 30 days
- •Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician
- •An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.
研究组 & 干预措施
UH-Participant
Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study.
干预措施: Belun Ring (Device)
UH-Participant
Potential participants with suspected OSA will be identified from the schedule of the UH Beachwood and Bolwell sleep labs.Those subjects who satisfy the study inclusion and exclusion criteria will be approached and invited to participate in the study.
干预措施: PSG (Diagnostic Test)
结局指标
主要结局
REI parameters
时间窗: 1 year
To determine the overall accuracy, sensitivity, and specificity of the BLS-100 in assessing OSA by comparing to the attended in-lab PSG in individuals referred to the sleep labs with clinical suspicion of OSA.
To Evaluate the Ability of the Belun Ring Pulse Oximeter to Gauge the Apnea-Hypopnea Index (AHI)
时间窗: 1 overnight sleep study (1 Day)
Apnea-Hypopnea Index (AHI) is defined as the total number of apnea and hypopnea events per hour of sleep, where higher values indicate more severe sleep-disordered breathing. In this study, standard overnight polysomnography(PSG) and Belun Ring pulse oximeter were simultaneously measured. The AHI derived from PSG data was served as the reference. The primary outcome evaluates the accuracy of the Belun Ring by calculating the difference in Ring-REI by the Belun Ring compared with AHI derived from PSG recordings for each participant. The difference was calculated as: Ring-REI (Belun Ring) - AHI (PSG). Negative values indicate that the Belun Ring estimated a lower AHI than PSG, while positive values indicate that the Belun Ring estimated a higher AHI than PSG. Summary statistics of these differences were used to assess agreement between the Belun Ring device and PSG in measuring sleep apnea severity.
次要结局
- Sleep stage parameters(1 year)
- Sleep Stage Parameters(1 overnight sleep study (1 Day))