Testing for Sleep Apnea in Adolescence Subjects With the WP200/WP200U Compared to an In-lab Overnight PSG Testing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
研究概览
简要总结
The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 12-17
- •Subjects with a legal guardian that is able to read understand and sign the informed consent form
- •Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab
排除标准
- •Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
- •Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
结局指标
主要结局
sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
时间窗: 1 night
correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
时间窗: 1 night
Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"
时间窗: 1 night
次要结局
未报告次要终点