Evaluation of ApneaLink Plus Scoring Capabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period
研究概览
简要总结
The purpose of this study is to investigate the following topics:
- Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.
- Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.
- Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet
详细描述
- Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.
- Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.
- Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Willing to give written informed consent
- •Adult patients who are 18 years of age or older
- •No alcohol consumption 12 hrs before and during the trial period
- •Normally sleep more than 3 hours per night
排除标准
- •Unable to comprehend written and spoken German.
- •Patients who use of Bilevel PAP or CPAP therapy during the PSG
- •Unsuitable for inclusion in the opinion of the investigator
结局指标
主要结局
Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period
时间窗: one night
Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts
Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)
时间窗: 1 night
The CAI (PSG) values and CAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)
时间窗: 1 night
The AHI (PSG) values and AHI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)
时间窗: 1 night
The AI (PSG) values and AI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)
时间窗: 1 night
The HI (PSG) values and HI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)
时间窗: 1 night
The ODI (PSG) values and ODI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)
时间窗: 1 night
The OAI (PSG) values and OAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \>75% will be seen as threshold for validity.
次要结局
未报告次要终点