Screening of Obstructive Sleep Apnea (OSA) in Hospitalized Patients Admitted for Acute Ischemic Stroke Using Belun Sleep Platform (BSP) - A Medical-Grade Wearable With Neural Network Algorithm
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- AHI, duration with SpO2 < 90%, and SpO2 nadir, as well as sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time)
研究概览
简要总结
Obstructive sleep apnea (OSA) is prevalent in patients with stroke and has a negative effect on outcomes by predisposing them to recurrent stroke, increasing mortality, and so forth. Therefore, it is extremely important to identify OSA in patients with stroke.
Wearable devices can greatly reduce the manpower and material requirements of traditional laboratory-based polysomnography (PSG). With Photoplethysmography (PPG) technology and neural network algorithms, the Belun ring and the sleeping platform not only can detect blood oxygen, and heart rate but also can identify sleep stage and estimate the severity of sleep apnea.
In this study, inpatients with acute ischemic stroke in the hospital will proceed with three nights test for recording the parameters of the autonomic nervous system in the acute phase, evaluate whether sleep apnea and the feasibility of the Belun sleep platform.
It is important that early recognition of OSA and prompt treatment, which can potentially improve OSA-associated adverse outcomes, as well as understanding the degree of autonomic nervous function impairment for patients with acute ischemic stroke. After smoothing this process, it can help clinicians more accurately comprehend the condition, timing of admission, and discharge.
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
- •Hospitalized patients with confirmed acute ischemic stroke
- •Age 18-80
- •Able to consent
排除标准
- •History of atrial fibrillation, LVEF < 45%, pacemaker/defibrillator, left ventricular assist device (LVAD), or status post-cardiac transplantation, devastating strokes ( mRS >= 4).
- •Aphasia, severe bulbar palsy, unable to comprehend, consent, or answer questionnaires.
- •Unstable cardiopulmonary status.
- •Recent surgery including tracheotomy in 30 days.
- •On narcotics.
- •On O2, PAP device, ventilator, diaphragmatic pacing, or any form of nerve stimulator
- •unable to understand instructions or to accurately use BRP during the instruction session.
- •Patients with technically valid recording time under 4 hours will be excluded.
结局指标
主要结局
AHI, duration with SpO2 < 90%, and SpO2 nadir, as well as sleep stage parameters (total sleep time [TST], wake time, REM time, and NREM time)
时间窗: 1 year
To specifically assess the accuracy of BSP bAHI in predicting OSA by comparing to the concurrent in-lab PSG-AHI and to determine the accuracy of BSP sleep stage parameters by comparing to the concurrent PSG. BSP bAHI, BSP time with SpO2 \< 90%, and BSP-SpO2 nadir will be extracted from BSP and compared to PSGAHI (4% hypopnea criteria), PSG time with SpO2 \< 90% (PSG-T90), PSG-SpO2 nadir extracted from the concurrent PSG. BSP sleep stage parameters (total sleep time \[TST\], wake time, REM time, and NREM time) will be extracted from BSP and compared to the same parameters of the concurrent PSG. Epoch-by-epoch comparison will be performed.
次要结局
- Duration of BSP use and technically valid recording time(1 year)
- Score of STOP-Bang(1 year)
- HRV parameters (including both frequency and time domain) ,the length of hospital stay, NIH Stroke Scale (NIHSS) score, and modified Rankin score (mRS)(1 year)
研究者
Wen-De Liu
Director of Sleep Center
Taipei Medical University Shuang Ho Hospital