A comparison of WatchPAT and Belun ring device for the diagnosis of obstructive sleep apnea
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the correlation of AHI as measured by Belun Ring Device as compared to that by Level-1 polysomnography for the diagnosis of OSA
研究概览
简要总结
The currently available gold-standard device for the diagnosis of OSA is in-lab PSG which requires patients to visit a sleep lab and stay overnight. However, this may be uncomfortable to many and may hamper their sleep leading to inadequate data acquisition. Newer portable devices for monitoring in home environments have been developed; however, validation in clinical settings is lacking for some of them. We recently validated one such device watchPAT 200; however, another new device Belun ring is yet to be validated in Indian subjects. The study will also explore whether having increased arterial stiffness will impact the performance of the device.
Belun ring device is an easy to use and does not have any additional costs of the device as in WatchPAT and is available just as a finger-worn ring. If this device is validated in Indian subjects, it will definitely impact the ease of conducting the sleep study and help in the early diagnosis of OSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with clinical suspicion of OSA, who are referred for a sleep study
- •Participants should be able to understand and comply with the study procedures and requirements.
排除标准
- •Participants with a previous diagnosis of obstructive sleep apnea or receiving treatment for the same
- •Participants who are unable or unwilling to provide informed consent
- •Individuals with a history of significant psychiatric disorders or cognitive impairment that may interfere with their ability to participate or comply with the study requirements
- •Pregnant women or individuals who are breastfeeding
- •Patients with known peripheral arterial disease or any other condition that can affect the accuracy of peripheral arterial tonometry measurements
- •Inadequate data acquisition during level 1 polysomnography (less than 120 minutes of sleep time).
结局指标
主要结局
To assess the correlation of AHI as measured by Belun Ring Device as compared to that by Level-1 polysomnography for the diagnosis of OSA
时间窗: At baseline
次要结局
- To assess the correlation of AHI as measured by Belun ring device as compared to that by WatchPAT 200 for the diagnosis of OSA(At baseline)
- To assess the correlation between Time spent below 90% saturation between the two devices(At baseline)
- To assess the correlation between ODI (Oxygen desaturation Index), total sleep time, and sleep efficiency between Belun ring device and WatchPAT 200(At baseline)
- To assess the effect of stiffness index as measured using Artsens device on the correlation of AHI between the three devices in a subgroup of patients(At baseline)
研究者
Saurabh Mittal
All India Institute of Medical Sciences, Delhi