Diagnosis of Sleep-related Respiratory Disorders in Patients With Cardiac Disorders Such as Atrial Fibrillation, Heart Failure and Other Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG
研究概览
简要总结
Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a synchronized manner.
The PSG data will be scored manually by a trained polysomnographic scorer, according to standard criteria for this clinical routine.
The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep stages, snoring (optional) and body position (optional), in addition to parameters specific to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and will be compared to the PSG's manual scoring which serves as a "Gold Standard".
详细描述
Subjects with cardiac disorders, referred to the sleep lab will be offered to participate in the study. Subjects will be asked to sign an informed consent form and will be screened for inclusion exclusion criteria.
Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate pre-study electronic case report forms.
The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP 200/WP200U wrist device, which includes the PAT and pulse oximeter probes will be worn on the wrist.
The investigator will not have access to the WP200/WP200U data while scoring the PSG data. During the study recording, the WP200/WP200U data will be recorded inside the device, without being displayed on the PSG monitor. Furthermore, the WP200/WP200U analysis is done automatically without knowledge of the PSG scoring results.
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
- 17 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between17-90
- •Subject is able to read understand and sign the informed consent form.
- •Subject with diagnosed cardiac disorders and/or other comorbidity
- •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
- •Finger deformity that precludes adequate sensor appliance.
- •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
Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG
时间窗: Within 1 year after data collection is complete.
calculation of the sensitivity, specificity, agreement and 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" disorders for subjects with cardiac disorders and/or comorbidities, to the manual scoring of the PSG that serves as a "gold standard".
次要结局
未报告次要终点