NCT04676191已完成不适用
Single- Center Performance Assessment of a Contactless Sensor for Vital Physiological Parameters Measurement at Rest and Detection of Diagnostic Indices in Sleep Compared to Cardiorespiratory Polygraphy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sleepiz AG
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Respiration rate measurement accuracy agreement
研究概览
简要总结
The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18years
- •Ability and consent to undergo electrophysiological routine assessment
- •Informed Consent as documented by signature
- •Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
- •Ambulatory or stationary patients of Klinik Lengg
排除标准
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Cardiac pacemaker or another implanted electrical device
- •Women who are pregnant
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
结局指标
主要结局
Respiration rate measurement accuracy agreement
时间窗: 60 seconds
次要结局
- Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician(1 Night)
- Average respiration rate agreement between Sleepiz One+ and nasal cannula(1 Night)
- Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician(60 seconds)
- Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt(1 Night)
- Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula(60 seconds)
研究者
研究点 (1)
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