Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)
研究概览
简要总结
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
详细描述
The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.
The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 18 years of age or older
- •Participant is willing to provide informed consent
- •Participant is willing to participate in all study related procedures
排除标准
- •Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)
- •Requires use of oxygen therapy during sleep
- •Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)
- •Participant is unsuitable to participate in the study in the opinion of the investigator
结局指标
主要结局
Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)
时间窗: Day 1
The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines. The REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.
次要结局
- Positive Likelihood Ratio of Apnealink Air(Day 1)
- Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG(Day 1)
- Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events(Day 1)