Accuracy of Detection and Reporting of Sleep-disordered Breathing Metrics Determined by the ResMed AirSense 10 in AirView
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ResMed
- 试验地点
- 4
- 主要终点
- To evaluate the diagnostic accuracy of the AirSense 10 Apnea-Hypopnea-Index (AHI) algorithm compared to polysomnography (PSG) scored AHI.
研究概览
简要总结
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG). 100 patients will be observed in a sleep facility under PSG and AirSense treatment.
详细描述
Sleep disordered breathing is commonly assessed by calculating an Apnea-Hypopnea-Index AHI and a Hypopnea-Index HI to define how frequent breathing or breathing efforts stop during the night. The severity of sleep apnea (SA) is determined by the number of occurring apneas and hypopneas. The respiratory disturbance index (RDI) captures these events and is calculated comprising an AHI but also RERAs via the flow signal. Polysomnography (PSG) is being used in the sleep laboratory as the Gold standard method to document a patient's sleep behavior by tracking air flow, respiratory effort, blood oxygen and electrocardiac as well as electromyographic signals. This way a comprehensive sleep pattern analysis can be created and different forms of SA can be detected. However, the method is laborious and cost-intensive, so it could save time and costs to have events accurately scored by the device itself. Device data become important when tracking a patient's sleep night by night and not only once. Reliable sleep data can be a valuable tool for tailoring sleep therapy to specific patient's needs. Accurate device data also build the foundation for analysis of large amounts of data, which can help us understanding how sleep disorders develop.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years who are able to understand and follow the instructions of the study personnel
- •Patients with an indication for PAP therapy or currently adherent to PAP therapy (device usage ≥4 h/ night) for moderate to severe sleep apnoea and diagnostic AHI ˃15/h and/or a residual CAI ˃5/h
- •Patients with currently titrated fixed CPAP pressure ≥8 cmH2O; or 95th percentile APAP pressure ≥8 cmH2O; or ASV therapy with a 95th percentile IPAP of ≥8 cmH2O
- •Patients who are established PAP users (PAP use duration ≥6 weeks)
- •Dated and signed written informed consent
排除标准
- •Patients with moderate to severe obstructive airway disease and/or respiratory insufficiency
- •Patients with heart failure in NYHA class III or IV, unstable hypertension, paroxysmal/persistent atrial fibrillation, unstable angina pectoris, cardiac or cerebral ischemic events within the last 6 months before screening
- •Patients with current primary or secondary insomnia
- •Patients who are pregnant or breastfeeding
- •Patients who are physically unable to comply with the protocol
研究组 & 干预措施
AirSense 10 AutoSet for Her
Treatment for 1 night with ResMed AirSense 10 AutoSet for Her. Intervention: Administration of PAP Treatment with suboptimal pressure for 1 night.
干预措施: AirSense 10 AutoSet for Her (Device)
结局指标
主要结局
To evaluate the diagnostic accuracy of the AirSense 10 Apnea-Hypopnea-Index (AHI) algorithm compared to polysomnography (PSG) scored AHI.
时间窗: 1 night
Calculate accuracy of the device when scoring Apnoeas and Hypopneas by comparing to polysomnography scoring. Identify Apneas (at least 90% decrease of airflow for at least 10 seconds) and Hypopneas (decrease of airflow by at least 30% for at least 10 seconds accompanied by a reduction of Oxygen Saturation of 4%) and calculate the apnea-hypopnea-index (AHI): (apneas + hypopneas)/hours of sleep.
次要结局
- To evaluate the diagnostic accuracy of the AirSense 10 Apnea-Hypopnea-Index (AHI) detection compared to polysomnography (PSG) gold standard scored AHI for clinical relevant threshold values.(1 night)
- To evaluate the diagnostic accuracy of the AirSense 10 Obstructive Apnea-Index (OAI) detection compared to polysomnography (PSG) gold standard scored OAI.(1 night)
- To evaluate the diagnostic accuracy of the AirSense 10 Central Apnea-Index (CAI) detection compared to polysomnography (PSG) gold standard scored CAI.(1 night)
- Sensitivity, specificity and accuracy of sleep efficiency as derived from the sleep state detection algorithm of the AirSense10 for Her(1 night)
- To evaluate the diagnostic accuracy of the AirSense 10 Respiratory-Disturbance-Index (RDI) detection compared to polysomnography (PSG) gold standard scored RDI.(1 night)
- Evaluate the diagnostic accuracy of the AirSense 10 Respiratory Effort Related Arousals (RERA) detection compared to polysomnography (PSG) gold standard scored RERA.(1 night)
- To evaluate the diagnostic accuracy of AirView AHI reporting compared to reporting via ResScan (SD card data)(1 night)
- To evaluate the diagnostic accuracy of AirView RDI reporting compared to reporting via ResScan (SD card data).(1 night)
- Sensitivity, specificity and accuracy of the sleep state detection algorithm of the AirSense10 for Her(1 night)