NCT04670848已完成不适用
Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sleepiz AG
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
研究概览
简要总结
In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18years
- •Ability and consent to undergo electrophysiological routine assessment
- •Patients suspected to suffer from sleep apnea or any other sleep related disorder
排除标准
- •Previous enrollment into the current study,
- •Enrollment of the investigator, his/her family members and other dependent persons
- •Cardiac pacemaker or another implanted electrical device
- •Women who are pregnant or breastfeeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
研究组 & 干预措施
Patients suspected of suffering from sleep apnea
Experimental
干预措施: Sleepiz One+ vs. polysomnography (Device)
Healthy volunteers
Experimental
干预措施: Sleepiz One+ vs. polysomnography (Device)
结局指标
主要结局
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
时间窗: 1 Night
次要结局
未报告次要终点
研究者
研究点 (1)
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