NCT06070389已完成不适用
Polysomnography Validation of the Sansa Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 4
- 主要终点
- Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
研究概览
简要总结
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
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
- 是
入选标准
- •18 years of age or older
- •able to read, understand, and sign informed consent documentation
- •willing to sleep with the Sansa device and PSG simultaneously in the sleep clinic
- •suspected or known to have sleep disordered breathing
排除标准
- •exhibit deformities of the chest that would interfere with sensor placement
- •have broken or injured skin that would interfere with sensor placement
- •known to experience adverse reactions to medical-grade adhesive
- •diagnosed with hypoventilation
- •diagnosed with severe chronic obstructive pulmonary disease
- •exhibit symptoms of significant non-respiratory sleep disorders
- •diagnosed with a neuromuscular disorder leading to muscle weakness
- •chronically use supplemental oxygen at night or during the day
- •scheduled to undergo titration of a hypoglossal nerve stimulation device
- •undergo permanent pacing with an implanted pacemaker
- •diagnosed with congestive heart failure with an ejection fraction less than 45%
结局指标
主要结局
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
时间窗: 1 night
次要结局
未报告次要终点
研究者
研究点 (4)
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