Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.
详细描述
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult subjects ( greater than 18 years of age) of either gender or any race
- •Suspected sleep disordered breathing
- •Untreated sleep disordered breathing
- •Willingness to use AL at home within 2 days of receipt and instruction on the AL
- •Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test
排除标准
- •Any subject requiring home oxygen therapy
- •Any subject currently receiving positive airway pressure therapy
结局指标
主要结局
Sensitivity and Specificity
时间窗: Simultaneous single night recording
Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater
次要结局
未报告次要终点