A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).
研究概览
简要总结
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.
详细描述
The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.
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
- •Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
- •Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
- •Subject is able to and willingly signs the informed consent form.
排除标准
- •Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
- •Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.
结局指标
主要结局
Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).
时间窗: 9 Hours
Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).
次要结局
未报告次要终点