Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Variability in mean oxygen saturation
研究概览
简要总结
The investigators would like to evaluate the variability of oxygen (and PPG) parameters during 7 nights at home. Oxygen (and PPG) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography).
Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.
详细描述
The main objective of this trial is to evaluate the variability in nocturnal oxygen (and PPG) parameters during 7 consecutive nights at home and to identify clinical predictors of variability in patients with suspected OSA.
Data regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability).
Additional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography.
The investigators will also evaluate variability in the surrogate AHI described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and PPG) parameters on the recently developed mICS algorithm will be explored.
This study is a first explorative approach for further (multi-site) work to define the burden of OSA associated with cardiovascular or psychofunctional problems.
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
- •Patients with suspected OSA with a clinical indication to perform a polysomnography
排除标准
- •Patients younger than 18 yrs
- •Patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues
- •Patients with neuromuscular disease or chest wall disease with suspected hypoventilation
结局指标
主要结局
Variability in mean oxygen saturation
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
Variability in percentage of time oxygen saturation < 88 percent
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
Variability in oxygen desaturation index 3 percent
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in number of oxygen desaturation events with desaturation higher or equal to 3% is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
Variability in percentage of time oxygen saturation < 90 percent
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
Variability in percentage of time oxygen saturation < 80 percent
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
Variability in oxygen desaturation index 4 percent
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in number of oxygen desaturation events with desaturation higher or equal to 4% is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
Variability in minimal oxygen saturation
时间窗: 7 nights
Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated. Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).
次要结局
- Variability in surrogate AHI(7 nights)
- Evaluation of clinical predictors (body position) of this variability.(7 nights)
- Evaluation of clinical predictors (alcohol intake, sleep duration) of this variability.(7 nights)
- To compare nocturnal oxygen (and PPG) parameters measured at home and during a diagnostic polysomnography in hospital.(8 nights (7 nights at home and 1 night in the hospital))
- Variability in cardiovascular comorbidity(7 nights)