Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Apnea/hypopnea index
研究概览
简要总结
To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.
详细描述
A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
- •able to sign an informed consent
排除标准
- •Pregnancy
- •Serious disease which could affect ability to complete the study
- •Complicated sleep disorders
结局指标
主要结局
Apnea/hypopnea index
时间窗: 72 hours
Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep
次要结局
- Sleep score(12 weeks)
